FDA 510(k) Premarket Notification K080818: HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING

Submission Details & Decision

Normalized public record details for 510(k) notification K080818.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K080818

Applicant / Sponsor

Hem Con Medical Technologies, Inc.

Device Name

HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING

Product Code

QSY

Decision Date

2008-05-15

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Unknown ()

Clearance Type

Traditional

Third Party Flag

Date Received

2008-03-24

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