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510(k) K882641

TECNOL CATHETER LEG STRAP by Tecnol New Jersey Wound Care, Inc. — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1988
Date Received
June 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
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)

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