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510(k) K973420

CLINITEX CAST PADDING by Clinitex Medical Corp. — Product Code LGF

K973420 is an FDA 510(k) premarket notification submitted by Clinitex Medical Corp. for the device "CLINITEX CAST PADDING". The FDA issued a decision of Substantially Equivalent on December 9, 1997. The device falls under product code LGF (Component, Cast), a Class I device regulated under 21 CFR 888.5940. Clinitex Medical Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1997
Date Received
September 10, 1997
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

Other clearances by Clinitex Medical Corp.

  • K973417 — CLINITEX STOCKINETTE (December 9, 1997)

Other clearances for product code LGF

  • K043526 — SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (March 10, 2005)
  • K973417 — CLINITEX STOCKINETTE (December 9, 1997)
  • K955320 — PROTEC COTTON PADDING BANDAGE (January 26, 1996)
  • K932507 — QUICK-CAST IMMOBILIZER (February 23, 1994)
  • K931672 — CARAPACE STERILE CAST PADDING (December 15, 1993)
  • K910274 — ARTIFLEX(TM) (March 5, 1991)
  • K903946 — COOL CAST(R) (December 31, 1990)
  • K896634 — CARAGLAS XTRA SYNTHETIC CASTING TAPE (June 14, 1990)
  • K883294 — SYNTHETIC CAST TAPE (August 30, 1988)
  • K874880 — COLORED CASTING TAPE CARAGLAS(TM GREEN (December 30, 1987)

FDA data resources