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510(k) K103011

ULTICARE SAFETY INSULIN SYRINGE by Ulti-Med Intl., Inc. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2011
Date Received
October 12, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Ulti-Med Intl., Inc.

  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K923175 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K920989 — SURGICAL INSTRUMENT KIT, DISPOSABLE (October 19, 1992)
  • K922828 — ULCER WOUND TRAY (September 28, 1992)
  • K914244 — STERILE CUSTOM SURGICAL KITS (February 24, 1992)
  • K914431 — ABSORBENT FIBER (December 4, 1991)
  • K912693 — POST OPERATIVE SPONGE (October 4, 1991)
  • K912692 — CONFORMING BANDAGE (October 4, 1991)
  • K904896 — EYE PAD (December 5, 1990)
  • K901465 — ABSORBABLE GAUZE DRAPE (June 12, 1990)

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