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510(k) K821529

DISPOSABLE HYPODERMIC NEEDLES by Medcare Disp Products, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1982
Date Received
May 21, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Medcare Disp Products, Inc.

  • K841949 — DOSE RELEASE OF STERILIZATION LOTS (September 5, 1984)
  • K841405 — INJECTION CAP OR ADAPTOR (April 4, 1984)
  • K840924 — SYRINGE, PISTON, ARTERIAL BLOOD SAMPL (March 23, 1984)
  • K821528 — SYRINGE, PISTON (June 9, 1982)
  • K821530 — SYRINGE IRRIGATING (May 28, 1982)

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