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510(k) K811184

SPENCO DERMAL PADS by Spenco Medical Corp. — Product Code FMP

K811184 is an FDA 510(k) premarket notification submitted by Spenco Medical Corp. for the device "SPENCO DERMAL PADS". The FDA issued a decision of Substantially Equivalent on May 20, 1981. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450. Spenco Medical Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1981
Date Received
April 29, 1981
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 Spenco Medical Corp.

  • K981902 — SPENCO SILICONE GEL SHEET (June 25, 1998)
  • K922228 — 2ND SKIN STERILE ADHESIVE STRIP (December 11, 1992)
  • K911550 — 2ND SKIN MOIST BURN PADS WITH ALOE (September 6, 1991)
  • K910927 — SPENCIO SKIN GUARD KIT (June 3, 1991)
  • K896533 — SPENCO BREAST FORMS (December 13, 1989)
  • K894898 — 2ND SKIN NON-STICK MOIST BURN PADS (August 23, 1989)
  • K820906 — SPENCO CRYOPRESS (May 13, 1982)
  • K791726 — HYDROGEL-PREP (November 20, 1979)
  • K791162 — GELSKIN (September 4, 1979)

Other clearances for product code FMP

  • K150243 — Invictus Medical GelShield (May 1, 2015)
  • K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING (July 31, 1995)
  • K934731 — MEDSURG STERILE IMAGING PRODUCTS (March 28, 1994)
  • K820584 — DECUBICARE PADS & ACCESSORIES (March 25, 1982)
  • K812344 — HEEL OR ELBOW PROTECTOR (September 11, 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