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510(k) K881363

SYRINGE PREFILLED WITH WATER by I M, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1988
Date Received
March 31, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by I M, Inc.

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  • K892389 — BIOPSY KIT (July 17, 1989)
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  • K872741 — NUTRIPUMP (October 20, 1987)
  • K871495 — BANDAGES CATALOG NUMBER: 101 TO 220 (May 8, 1987)
  • K863785 — MAKLER CATHETER (December 11, 1986)
  • K854155 — STERILE SALINE SOLUTION (December 10, 1985)
  • K853287 — HUBOUT (October 17, 1985)
  • K853288 — FEEDING UNITS & TUBES (October 4, 1985)
  • K853286 — STAPLE REMOVER (August 21, 1985)

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