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510(k) K894906

ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER by Med-Tek Corp. — Product Code BTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1989
Date Received
August 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Reservoir
Device Class
Class I
Regulation Number
868.5320
Review Panel
AN
Submission Type

Other clearances by Med-Tek Corp.

  • K903234 — F-19 TOTAL HIP PROSTHESIS (October 10, 1990)
  • K901687 — F-24 FEMORAL HIP PROSTHESIS (September 7, 1990)
  • K901451 — F-20 CEMENTED METAL-BACKED ACETABULAR CUP (August 31, 1990)
  • K900428 — ANESTHESIA BREATHING CIRCUITS (August 17, 1990)
  • K901626 — H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED (August 14, 1990)
  • K901594 — H.N. TOTAL HIP PROSTHESIS (August 3, 1990)
  • K901480 — F-20 TOTAL HIP PROSTHESIS (June 12, 1990)
  • K901273 — L.M.S. SELF-DETACHABLE BROACH WITH STOP (June 5, 1990)
  • K901272 — ORION BLADE PLATE FOR TIBIAL OSTEOTOMY (April 23, 1990)
  • K901240 — ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED (March 26, 1990)

Other clearances for product code BTC

  • K181424 — PeDIA (September 25, 2018)
  • K940220 — REBREATHER BAGS (May 27, 1994)
  • K932584 — BREATHING BAGS (July 16, 1993)
  • K932496 — PRECISION MED PRODUCTS, LTD. BREATHING BAGS (July 16, 1993)
  • K932581 — BREATHING BAGS (July 16, 1993)
  • K932191 — BREATHING BAGS (July 2, 1993)
  • K880680 — KING SYSTEMS, BREATHING BAG (March 3, 1988)
  • K864822 — VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (January 15, 1987)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)