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510(k) K841275

FINE NEEDLE ASPIRATION DEVICE by Gyneco, Inc. — Product Code DRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1984
Date Received
March 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Cardiac, External
Device Class
Class II
Regulation Number
870.5200
Review Panel
CV
Submission Type

Other clearances by Gyneco, Inc.

  • K861409 — SYNCARE TEMPORARY CARDIAC PACING WIRE (May 5, 1986)
  • K853216 — MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 (April 2, 1986)
  • K852357 — GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP (July 5, 1985)
  • K843941 — ENDOCYTE (February 25, 1985)

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