FDA 510(k) Premarket Notification K963512: BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL

Submission Details & Decision

Normalized public record details for 510(k) notification K963512.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K963512

Applicant / Sponsor

Benz Research and Development Corp.

Device Name

BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL

Product Code

HQD

Decision Date

1997-07-31

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ophthalmic (OP)

Clearance Type

Traditional

Third Party Flag

Date Received

1996-08-30

Related Establishments / Registrations

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ACCULENS, INC. Registration: 1720959 View Registration
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Synergy Health AST, LLC Registration: 2030598 View Registration
CONTEX, INCORPORATED Registration: 2031102 View Registration
CONTAMAC LTD. Registration: 3001190611 View Registration
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Menicon Co., Ltd., R&D Center Registration: 3003062331 View Registration
Menicon B.V. Registration: 3003357577 View Registration
SYNERGEYES, INC. Registration: 3005087645 View Registration
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Menicon Nect Co., Ltd., Gujo Plant Registration: 3010607087 View Registration
ACUITY POLYMERS INC. Registration: 3012228452 View Registration
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EUCLID VISION CORPORATION Registration: 3014175039 View Registration
Menicon Co., Ltd. Techno-station Registration: 3014769028 View Registration
HEDGEFOG RESEARCH INC. Registration: 3014964775 View Registration
Precision Technology Services Ltd Registration: 3020246591 View Registration
VALLEY CONTAX, INC Registration: 3022320387 View Registration
CLER VISION INC. Registration: 3022988037 View Registration
BIOLENS LAB Registration: 3025308027 View Registration
TIANJIN MASTERVISION TECHNOLOGY CO., LTD. Registration: 3032010300 View Registration
MENICON CO. LTD. Global Logistics Center Registration: 3033524682 View Registration
Visionary Optics, LLC Registration: 3043365583 View Registration
BLANCHARD VISION CORP. Registration: 9612500 View Registration
MENICON CO. LTD. Registration: 9614761 View Registration
Rommelag CDMO GmbH Registration: 9681630 View Registration

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