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510(k) K761268

SKIN PRESSURE PROTECTORS by Mark One Healthcare Products — Product Code FMP

K761268 is an FDA 510(k) premarket notification submitted by Mark One Healthcare Products for the device "SKIN PRESSURE PROTECTORS". The FDA issued a decision of Substantially Equivalent on February 16, 1977. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450. Mark One Healthcare Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1977
Date Received
December 16, 1976
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 Mark One Healthcare Products

  • K891986 — MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE (December 29, 1989)
  • K833867 — PAREMA K BAND NON-STERILE (January 27, 1984)
  • K833084 — MASTERHINGE (October 14, 1983)
  • K770396 — DRAPES, MODESTY (March 23, 1977)

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)
  • 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)

FDA data resources