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510(k) K931269

LEAD APRON by Bt Medical Co., Inc. — Product Code EAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1993
Date Received
March 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apron, Leaded
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances by Bt Medical Co., Inc.

  • K931268 — URETERAL COMPRESSION DEVICE (July 19, 1993)
  • K930885 — PNEUMATIC COMPRESSION DEVICE (July 13, 1993)
  • K915321 — BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR (July 17, 1992)
  • K914999 — BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED) (April 23, 1992)

Other clearances for product code EAJ

  • K913621 — RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR (September 27, 1991)
  • K870563 — X-RAY APRON (February 19, 1987)
  • K870103 — LEAD APRON CADDY (January 21, 1987)
  • K832601 — LEADED X-RAY APRON (September 29, 1983)
  • K832602 — THYROID PROTECTIVE COLLAR (September 29, 1983)