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510(k) K911204

QUALTEX SKIN STAPLE EXTRACTOR by Deroyal Industries, Inc. — Product Code GDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1991
Date Received
March 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Removable (Skin)
Device Class
Class I
Regulation Number
878.4760
Review Panel
SU
Submission Type

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