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510(k) K760772

DISPOSABLE ABDOMINAL BINDER by Tecnol New Jersey Wound Care, Inc. — Product Code FSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1976
Date Received
October 4, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Binder, Abdominal
Device Class
Class I
Regulation Number
880.5160
Review Panel
HO
Submission Type

Other clearances by Tecnol New Jersey Wound Care, Inc.

  • K913043 — MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS (August 23, 1991)
  • K911891 — FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK (July 12, 1991)
  • K911907 — FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS (July 8, 1991)
  • K896193 — TECNOL LAZER(TM) SURGICAL MASK (February 27, 1990)
  • K894205 — TECNOL SILK STRIP (July 25, 1989)
  • K893702 — TECNOL GAITERS PRODUCT NUMBER 47725-010 (June 23, 1989)
  • K891187 — TECNOL NASO-GASTRIC TUBE HOLDER (May 30, 1989)
  • K891178 — TECNOL SECURE-ALL TUBE HOLDER (May 23, 1989)
  • K884440 — TECNOL VARIABLE TENSION BANDAGE (January 17, 1989)
  • K882640 — TECNOL SECURE-ALL PELVIC TRACTION BELT (July 27, 1988)

Other clearances for product code FSD

  • K892379 — THE POUCH GROIN & ABDOMINAL STRESS AID (July 20, 1989)
  • K822817 — DOCE ALL-IN-THE-EAR AID (January 18, 1983)
  • K810379 — EARETTE HEARING AID SEARS #8054 (March 4, 1981)
  • K770162 — MATERNITY SUPPORTER (February 9, 1977)