FDA 510(k) Premarket Notification K011481: 10% PVP; 10% PVP IN EBSS SOLUTION

Submission Details & Decision

Normalized public record details for 510(k) notification K011481.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K011481

Applicant / Sponsor

Conception Technologies

Device Name

10% PVP; 10% PVP IN EBSS SOLUTION

Product Code

MQL

Decision Date

2001-07-02

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Obstetrics/Gynecology (OB)

Clearance Type

Traditional

Third Party Flag

Date Received

2001-05-14

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.