Home / 510(k) Clearances / K964534

510(k) K964534

OTOSILK OTOLOGICAL GRAFT DRESSING by Boston Medical Products, Inc. — Product Code NAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1997
Date Received
November 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

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