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510(k) K870383

ALGINATE WOOL FIBER by Adri — Product Code KHR

K870383 is an FDA 510(k) premarket notification submitted by Adri for the device "ALGINATE WOOL FIBER". The FDA issued a decision of Substantially Equivalent on April 30, 1987. The device falls under product code KHR (Absorber, Saliva, Paper), a Class I device regulated under 21 CFR 872.6050. Adri has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1987
Date Received
January 30, 1987
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 Adri

  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K011618 — CALGITROL AG SILVER ALGINATE WOUND DRESSING (November 15, 2002)
  • K000054 — FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN (March 13, 2000)
  • K963656 — FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING (November 12, 1996)
  • K940404 — ALGINATE FIBER TOPICAL WOUND DRESSING (May 4, 1994)

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)
  • 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