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510(k) K801195

DERMALEX OR NATRAWOOL SKIN PRESSURE PROT by Stock Wild & Co. — Product Code FMP

K801195 is an FDA 510(k) premarket notification submitted by Stock Wild & Co. for the device "DERMALEX OR NATRAWOOL SKIN PRESSURE PROT". The FDA issued a decision of Substantially Equivalent on June 9, 1980. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1980
Date Received
May 16, 1980
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

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  • 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)
  • K792297 — SPAN AIDS KIT (December 20, 1979)

FDA data resources