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510(k) K930313

APEX SPECIMEN BAG by Apex Medical Technologies, Inc. — Product Code LIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1993
Date Received
January 22, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

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  • K922688 — EXTRA PROTECTION POLYURETHANE CONDOM (May 4, 1995)
  • K902936 — POLYURETHANE CONDOM (March 6, 1991)
  • K871358 — SENSATIONS BRAND CONDOMS (March 1, 1989)
  • K874539 — HI-TOUCH (TM) BRAND SURGICAL GLOVES (December 14, 1987)

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