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510(k) K803144

CONPHAR CRUTCH PADS by Conphar, Inc. — Product Code INP

K803144 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR CRUTCH PADS". The FDA issued a decision of Substantially Equivalent on January 8, 1981. The device falls under product code INP (Tips And Pads, Cane, Crutch And Walker), a Class I device regulated under 21 CFR 890.3790. Conphar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1981
Date Received
December 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tips And Pads, Cane, Crutch And Walker
Device Class
Class I
Regulation Number
890.3790
Review Panel
PM
Submission Type

Other clearances by Conphar, Inc.

  • K821825 — CONPHAR SILICONE FEEDING TUBE (August 10, 1982)
  • K821295 — OLSEN HEGAR NEEDLE HOLDERS (June 3, 1982)
  • K821289 — MAYO-HEGAR NEEDLE HOLDER (June 3, 1982)
  • K821354 — CONPHAR MAYO HEGAR NEEDLE HOLDER (June 3, 1982)
  • K821282 — THUMB DRESSING FORCEPS 5 (May 28, 1982)
  • K821248 — ROCHESTER PEAN FORCEPS (May 28, 1982)
  • K821276 — MAYO SCISSOR CURYED 5 1/2 (May 28, 1982)
  • K821273 — MAYO SCISSOR STRAIGHT 6 3/4 (May 28, 1982)
  • K821298 — BACKHAUS CLAMP, 3 1/2 (May 28, 1982)
  • K821285 — SPLINTER FORCEPS 4 1/2 (May 28, 1982)

Other clearances for product code INP

  • K831889 — SURGEON'S CHOICE CRUTCH HANDLE (July 7, 1983)
  • K831149 — PERSONAL KNEE CRUTCH PAD (May 3, 1983)
  • K811493 — CRUTCH & WALKER PADS (June 12, 1981)
  • K810650 — CRUTCH TIPS & GRIPS (March 26, 1981)
  • K803140 — CONPHAR CRUTCH GRIPS (January 8, 1981)
  • K803136 — CONPHAR CRUTCH TIPS (January 8, 1981)
  • K800076 — CRUTCH TIPS, PADS & HAND GRIPS (January 28, 1980)

FDA data resources