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510(k) K803141

CONPHAR CAST HEELS by Conphar, Inc. — Product Code LGF

K803141 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR CAST HEELS". The FDA issued a decision of Substantially Equivalent on Jan 9, 1981. The device falls under product code LGF (Component, Cast), a Class I device regulated under 21 CFR 888.5940. Conphar, Inc. has 121 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 9, 1981
Date Received
Dec 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Component, Cast
Device Class
Class I
Regulation Number
888.5940
Review Panel
OR
Submission Type
510(k) Exempt

Other clearances by Conphar, Inc.

  • K821825 — CONPHAR SILICONE FEEDING TUBE (Aug 10, 1982)
  • K821295 — OLSEN HEGAR NEEDLE HOLDERS (Jun 3, 1982)
  • K821354 — CONPHAR MAYO HEGAR NEEDLE HOLDER (Jun 3, 1982)
  • K821289 — MAYO-HEGAR NEEDLE HOLDER (Jun 3, 1982)
  • K821273 — MAYO SCISSOR STRAIGHT 6 3/4 (May 28, 1982)
  • K821248 — ROCHESTER PEAN FORCEPS (May 28, 1982)
  • K821282 — THUMB DRESSING FORCEPS 5 (May 28, 1982)
  • K821276 — MAYO SCISSOR CURYED 5 1/2 (May 28, 1982)
  • K821285 — SPLINTER FORCEPS 4 1/2 (May 28, 1982)
  • K821290 — LITTAUER SCISSORS 5 1/2 (May 28, 1982)

Other clearances for product code LGF

  • K043526 — SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (Mar 10, 2005)
  • K973417 — CLINITEX STOCKINETTE (Dec 9, 1997)
  • K973420 — CLINITEX CAST PADDING (Dec 9, 1997)
  • K955320 — PROTEC COTTON PADDING BANDAGE (Jan 26, 1996)
  • K932507 — QUICK-CAST IMMOBILIZER (Feb 23, 1994)
  • K931672 — CARAPACE STERILE CAST PADDING (Dec 15, 1993)
  • K910274 — ARTIFLEX(TM) (Mar 5, 1991)
  • K903946 — COOL CAST(R) (Dec 31, 1990)
  • K896634 — CARAGLAS XTRA SYNTHETIC CASTING TAPE (Jun 14, 1990)
  • K883294 — SYNTHETIC CAST TAPE (Aug 30, 1988)

FDA data resources

Source: FDA 510(k) database entry for K803141. Report a data issue: hello@regdatalab.com.