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510(k) K980783

SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 by Irt Management Corp. — Product Code KHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1998
Date Received
March 2, 1998
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

Other clearances by Irt Management Corp.

  • K980672 — SIMPLEX AIRBRATOR (SAB-7) (May 4, 2000)

Other clearances for product code KHR

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  • K953812 — GAUZE SPONGE (October 2, 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)