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510(k) K925653

DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH by Dermatopathology Laboratory — Product Code MDM

K925653 is an FDA 510(k) premarket notification submitted by Dermatopathology Laboratory for the device "DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH". The FDA issued a decision of Substantially Equivalent on November 8, 1993. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1993
Date Received
November 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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FDA data resources