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510(k) K821285

SPLINTER FORCEPS 4 1/2 by Conphar, Inc. — Product Code EFL

K821285 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "SPLINTER FORCEPS 4 1/2". The FDA issued a decision of Substantially Equivalent on May 28, 1982. The device falls under product code EFL (Forceps, Dressing, Dental), a Class I device regulated under 21 CFR 872.4565. Conphar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1982
Date Received
May 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Dressing, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
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)
  • K821294 — TONSIL SCISSORS STRAIGHT 5 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 EFL

  • K890243 — DRESSING FORCEPS (January 27, 1989)
  • K821778 — BEACH DRESSING PLIER (July 6, 1982)
  • K821282 — THUMB DRESSING FORCEPS 5 (May 28, 1982)
  • K821284 — ADSON FORCEPS 4 3/4 (May 28, 1982)

FDA data resources