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510(k) K871478

SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS by Procedure Pak, Inc. — Product Code FSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1987
Date Received
April 14, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Procedure Pak, Inc.

  • K861288 — NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES (May 6, 1986)

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  • K910570 — SPLINTER TWEEZERS (May 31, 1991)
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  • K910328 — KEY COMFORT GRIPS (March 6, 1991)