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510(k) K895654

SORBEX(TM) SOFT SPONGE by Fountain Pharmaceuticals, Inc. — Product Code NAD

K895654 is an FDA 510(k) premarket notification submitted by Fountain Pharmaceuticals, Inc. for the device "SORBEX(TM) SOFT SPONGE". The FDA issued a decision of SN on February 20, 1990. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Fountain Pharmaceuticals, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SN ()
Decision Date
February 20, 1990
Date Received
September 20, 1989
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 Fountain Pharmaceuticals, Inc.

  • K904604 — REDI-RELEASE ABSORBENT DRESSING (January 7, 1991)

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