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510(k) K850988

BOVO MOISTURE GUARD by E.H. Medical Co. — Product Code KHR

K850988 is an FDA 510(k) premarket notification submitted by E.H. Medical Co. for the device "BOVO MOISTURE GUARD". The FDA issued a decision of Substantially Equivalent on April 16, 1985. The device falls under product code KHR (Absorber, Saliva, Paper), a Class I device regulated under 21 CFR 872.6050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1985
Date Received
March 11, 1985
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 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)
  • 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)
  • K780400 — DEN-Z-ORB (March 27, 1978)
  • K771908 — ISO-SHIELD SALIVA ABSORBERS (November 7, 1977)

FDA data resources