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510(k) K882696

DERMICEL, MONTGOMERY STRAP by Bioseal — Product Code NAD

K882696 is an FDA 510(k) premarket notification submitted by Bioseal for the device "DERMICEL, MONTGOMERY STRAP". The FDA issued a decision of Substantially Equivalent on August 26, 1988. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Bioseal has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1988
Date Received
June 27, 1988
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 Bioseal

  • K893814 — SURGICAL INSTRUMENT KIT, DISPOSABLE (August 10, 1989)
  • K882695 — RUBBER BAND, STERILE (October 13, 1988)
  • K882694 — FIXATION DEVICE, TRACH TUBE (August 15, 1988)
  • K882709 — TONSIL SPONGE, X-RAY DETECTABLE, W/STRING (August 3, 1988)
  • K882711 — GAUZE SPONGE 12PLY (August 3, 1988)
  • K882712 — STICK SPONGE (August 3, 1988)
  • K882707 — GAUZE PACKING, X-RAY DETECTABLE (August 3, 1988)
  • K882708 — GAUZE SPONGE, X-RAY DETECTABLE (August 3, 1988)
  • K882710 — INTESTINAL SPONGES (August 3, 1988)

Other clearances for product code NAD

  • K254246 — LT Antibacterial Foam with Silver Dressing (September 10, 2026)
  • 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)

FDA data resources