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510(k) K900310

REPEL SURGICAL GLOVE LINERS by Depuy-Raynham — Product Code LYU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1990
Date Received
January 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Surgical Apparel
Device Class
Class I
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Depuy-Raynham

  • K914077 — REPEL(TM) LITE CUT RESISTANT GLOVE LINERS (December 2, 1991)
  • K910941 — LIFELINER SURGICAL GLOVE (May 9, 1991)

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  • K964364 — DISPOSABLE APRON (February 25, 1997)
  • K961791 — DEPUY DISPOSABLE FILTER/HOOD (August 9, 1996)
  • K961454 — AMMI MAGNI-GUARD (July 25, 1996)
  • K945302 — SLOAN STA-DRI PANT PROTECTOR (March 19, 1996)
  • K954314 — ULTRAFIT LINERS (December 28, 1995)
  • K953089 — I-SPOUSE (October 16, 1995)
  • K952303 — SPLASH ASSIST (August 24, 1995)