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510(k) K953812

GAUZE SPONGE by Remington Medical, Inc. — Product Code KHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1995
Date Received
August 2, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Absorber, Saliva, Paper
Device Class
Class I
Regulation Number
872.6050
Review Panel
DE
Submission Type

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Other clearances for product code KHR

  • K980783 — SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 (April 21, 1998)
  • K954068 — GENERAL HYGIENE KIT (November 8, 1995)
  • K891054 — NON-STERILE GAUZE SPONGE (May 1, 1989)
  • K891354 — ORTHODONTIC COTTON ROLL HOLDERS (April 17, 1989)
  • K890734 — DRY TIPS (March 10, 1989)
  • K870383 — ALGINATE WOOL FIBER (April 30, 1987)
  • K850988 — BOVO MOISTURE GUARD (April 16, 1985)
  • K780400 — DEN-Z-ORB (March 27, 1978)
  • K771908 — ISO-SHIELD SALIVA ABSORBERS (November 7, 1977)