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510(k) K854740

PRIMADERM by Absorbent Cotton Co., Inc. — Product Code NAD

K854740 is an FDA 510(k) premarket notification submitted by Absorbent Cotton Co., Inc. for the device "PRIMADERM". The FDA issued a decision of SN on March 14, 1986. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Absorbent Cotton Co., Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 14, 1986
Date Received
November 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances by Absorbent Cotton Co., Inc.

  • K883250 — STERI-CLENS WOUND CARE KIT (August 26, 1988)
  • K880613 — ACCO(R) FACE MASK (March 4, 1988)
  • K875129 — STERI-CLENS (February 18, 1988)
  • K874741 — STERI-CLENS(TM) SURGICAL SCRUB SPONGE (December 10, 1987)
  • K873523 — PLAIN DRY GAUZE (October 9, 1987)
  • K850126 — OIL EMULSION NON-ADHERING DRESSING (April 25, 1985)
  • K844095 — WET DRESSING WATER-STERILE (November 27, 1984)
  • K844096 — WET DRESSING SALINE-STERILE (November 19, 1984)
  • K781727 — CHANGE IN STERILIZATION PROCEDURE (December 4, 1978)

Other clearances for product code NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)

FDA data resources