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510(k) K993535

METAPAK MULTI-PURPOSE INSTRUMENT TRAY by Riley Medical, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2001
Date Received
October 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Riley Medical, Inc.

  • K944025 — SURGICAL INSTRUMENT TRAY (November 22, 1994)

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  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
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  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)