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510(k) K951325

COMFEEL PLUS PRESSURE RELIEF DRESSING by Richard Hamer Assoc., Inc. — Product Code FMP

K951325 is an FDA 510(k) premarket notification submitted by Richard Hamer Assoc., Inc. for the device "COMFEEL PLUS PRESSURE RELIEF DRESSING". The FDA issued a decision of Substantially Equivalent on July 31, 1995. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450. Richard Hamer Assoc., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1995
Date Received
March 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Skin Pressure
Device Class
Class I
Regulation Number
880.6450
Review Panel
HO
Submission Type

Other clearances by Richard Hamer Assoc., Inc.

  • K962439 — DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) (September 3, 1996)
  • K950934 — MPM HYDROGEL DRESSING (May 16, 1995)
  • K951327 — COMFEEL PLUS CONTOUR DRESSING (April 28, 1995)
  • K942283 — COMFEEL PLUS TRANSPARENT DRESSING (July 29, 1994)
  • K942573 — COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH (July 18, 1994)
  • K941263 — COMFEEL PLUS WOUND DRESSING (May 10, 1994)
  • K934839 — MESALT STERILE DRESSING (December 22, 1993)

Other clearances for product code FMP

  • K150243 — Invictus Medical GelShield (May 1, 2015)
  • K934731 — MEDSURG STERILE IMAGING PRODUCTS (March 28, 1994)
  • K820584 — DECUBICARE PADS & ACCESSORIES (March 25, 1982)
  • K812344 — HEEL OR ELBOW PROTECTOR (September 11, 1981)
  • K811184 — SPENCO DERMAL PADS (May 20, 1981)
  • K802829 — SCANLAN VASCU-STATT (January 15, 1981)
  • K802185 — ARTERIAL BLOOD SAMPLING KIT (October 10, 1980)
  • K801694 — FLOTATION PAD FOR OPERATING TABLE (August 27, 1980)
  • K801195 — DERMALEX OR NATRAWOOL SKIN PRESSURE PROT (June 9, 1980)
  • K792297 — SPAN AIDS KIT (December 20, 1979)

FDA data resources