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510(k) K974638

STERITITE SEALED CONTAINERS MODEL SCO4Q by Case Medical, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1997
Date Received
October 10, 1997
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

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Other clearances for product code FRG

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  • K242898 — Sterilization Pouches and Reels (February 21, 2025)