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510(k) K921228

BENDEREV PROTECT-A-PASS NEEDLE by Eimark Labs, Inc. — Product Code KOA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1992
Date Received
March 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Instruments, G-U, Manual (And Accessories)
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

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