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510(k) K952256

PICC LINE KIT by Medi-Flex Hospital Products, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1995
Date Received
May 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
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)
  • 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)
  • K921347 — CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER (January 8, 1993)

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