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510(k) K920398

CEPTI-SEAL DRESSING CHNG. KIT FOR CENT. VENOUS CAT by Medi-Flex Hospital Products, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1992
Date Received
January 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Medi-Flex Hospital Products, Inc.

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  • K952201 — PORT-A-CATH ACCESS KIT (October 4, 1995)
  • K952416 — TRACHEOSTOMY CARE KIT (August 9, 1995)
  • K952256 — PICC LINE KIT (July 31, 1995)
  • K952007 — ADHEROL SEPP APPLICATOR (June 8, 1995)
  • K934790 — SEPP ADHESIVE REMOVER (March 11, 1994)
  • K920399 — COMPOUND BENZOIN TINCTURE USP FREPP (January 25, 1994)
  • K923516 — COMPOUND BENZOIN TINCTURE USP SEPP (January 25, 1994)
  • K930196 — CEPTI-SEAL I.V. PREP KIT (July 2, 1993)

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