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510(k) K771519

SPECIALIST ARM & LEG PROTECTOR by Johnson & Johnson Professionals, Inc. — Product Code FMP

K771519 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "SPECIALIST ARM & LEG PROTECTOR". The FDA issued a decision of Substantially Equivalent on August 26, 1977. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1977
Date Received
August 8, 1977
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 Johnson & Johnson Professionals, Inc.

  • K992173 — SIPHONGUARD CSF CONTROL DEVICE (April 7, 2000)
  • K991413 — CODMAN ETHISORB DURA PATCH (March 13, 2000)
  • K991222 — CODMAN MICROSENSOR VENTRICULAR CATHETER KIT (July 9, 1999)
  • K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER (December 18, 1998)
  • K982812 — G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) (December 4, 1998)
  • K983141 — CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS (November 6, 1998)
  • K983014 — SUMMIT ACETABULAR SYSTEM (October 27, 1998)
  • K980778 — HAKIM MICRO PROGRAMMABLE VALVE SYSTEM (July 17, 1998)
  • K974739 — HAKIM PROGRAMMABLE VALVE SYSTEM (July 1, 1998)
  • K980801 — J-FX BIPOLAR HEAD (May 29, 1998)

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