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510(k) K781727

CHANGE IN STERILIZATION PROCEDURE by Absorbent Cotton Co., Inc. — Product Code GOY

K781727 is an FDA 510(k) premarket notification submitted by Absorbent Cotton Co., Inc. for the device "CHANGE IN STERILIZATION PROCEDURE". The FDA issued a decision of Substantially Equivalent on December 4, 1978. The device falls under product code GOY (Antisera, Agglutinating, B. Pertussis, All), a Class I device regulated under 21 CFR 866.3065. Absorbent Cotton Co., Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1978
Date Received
October 11, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Agglutinating, B. Pertussis, All
Device Class
Class I
Regulation Number
866.3065
Review Panel
MI
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)
  • K854740 — PRIMADERM (March 14, 1986)
  • 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)

FDA data resources