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510(k) K803139

CONPHAR ARM SLINGS by Conphar, Inc. — Product Code ILI

K803139 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR ARM SLINGS". The FDA issued a decision of Substantially Equivalent on January 8, 1981. The device falls under product code ILI (Sling, Arm), a Class I device regulated under 21 CFR 890.3640. 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
Sling, Arm
Device Class
Class I
Regulation Number
890.3640
Review Panel
PM
Submission Type

Other clearances by Conphar, Inc.

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

Other clearances for product code ILI

  • K912661 — MATRX, PYRAMID TRIANGLE BANDAGE (August 21, 1991)
  • K831549 — ARM SLINGS (June 30, 1983)
  • K831706 — SATO FAMILY FIRST AID KIT (June 24, 1983)
  • K823808 — VARIOUS ARM SLING (January 14, 1983)
  • K823810 — A.C. SPLINT (January 14, 1983)
  • K823664 — UNIVERSAL SLING, SLING & SWATHE (December 30, 1982)
  • K823162 — UNIVERSAL SLING, SLING & SWATHE (November 10, 1982)
  • K820590 — ORTHOPEDIC SOFT GOODS (March 26, 1982)
  • K812477 — ARM SLING, POUCH TYPE (September 14, 1981)
  • K812478 — MADDACOMFORT SLING (September 14, 1981)

FDA data resources