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510(k) K891054

NON-STERILE GAUZE SPONGE by Dispomed, Inc. — Product Code KHR

K891054 is an FDA 510(k) premarket notification submitted by Dispomed, Inc. for the device "NON-STERILE GAUZE SPONGE". The FDA issued a decision of Substantially Equivalent on May 1, 1989. The device falls under product code KHR (Absorber, Saliva, Paper), a Class I device regulated under 21 CFR 872.6050. Dispomed, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1989
Date Received
February 27, 1989
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 Dispomed, Inc.

  • K892748 — PATIENT EXAM GLOVES (MFG. AMMATEX) (August 10, 1989)
  • K891058 — DENTAL GOWN (April 12, 1989)
  • K891056 — SURGICAL CONE MASK (April 12, 1989)
  • K891052 — SPLASH GUARD GOGGLE (April 12, 1989)
  • K891053 — DENTAL BIB (April 12, 1989)
  • K891051 — SURGICAL FACE MASK-EAR LOOP (April 12, 1989)

Other clearances for product code KHR

  • K980783 — SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 (April 21, 1998)
  • K954068 — GENERAL HYGIENE KIT (November 8, 1995)
  • K953812 — GAUZE SPONGE (October 2, 1995)
  • 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)

FDA data resources