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510(k) K821077

CONPHAR by Conphar, Inc. — Product Code EGN

K821077 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR". The FDA issued a decision of Substantially Equivalent on May 24, 1982. The device falls under product code EGN (Scissors, Surgical Tissue, 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 24, 1982
Date Received
April 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, Surgical Tissue, 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)
  • 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 EGN

  • K932675 — GXP DENTAL X-RAY PROCESSOR (July 26, 1993)
  • K851720 — 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS (July 2, 1985)
  • K821276 — MAYO SCISSOR CURYED 5 1/2 (May 28, 1982)
  • K821294 — TONSIL SCISSORS STRAIGHT 5 1/2 (May 28, 1982)
  • K821275 — MAYO SCISSOR STRAIGHT 5 1/2 (May 28, 1982)
  • K821292 — TONSIL SCISSORS 7 (May 28, 1982)

FDA data resources