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510(k) K931268

URETERAL COMPRESSION DEVICE by Bt Medical Co., Inc. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1993
Date Received
March 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by Bt Medical Co., Inc.

  • K930885 — PNEUMATIC COMPRESSION DEVICE (July 13, 1993)
  • K931269 — LEAD APRON (June 2, 1993)
  • K915321 — BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR (July 17, 1992)
  • K914999 — BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED) (April 23, 1992)

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