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510(k) K954068

GENERAL HYGIENE KIT by Physician Industries, Inc. — Product Code KHR

K954068 is an FDA 510(k) premarket notification submitted by Physician Industries, Inc. for the device "GENERAL HYGIENE KIT". The FDA issued a decision of Substantially Equivalent (kit) on November 8, 1995. The device falls under product code KHR (Absorber, Saliva, Paper), a Class I device regulated under 21 CFR 872.6050. Physician Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
November 8, 1995
Date Received
August 30, 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

Other clearances by Physician Industries, Inc.

  • K040565 — PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE (July 22, 2004)
  • K033739 — PHYSICIAN INDUSTRIES' DURAMETER SYRINGE (July 12, 2004)
  • K960248 — GENERAL PROCEDURE KIT (April 12, 1996)

Other clearances for product code KHR

  • K980783 — SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 (April 21, 1998)
  • 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)

FDA data resources