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510(k) K791463

PARA-VENT by Cameron Medical Corp. — Product Code BTC

K791463 is an FDA 510(k) premarket notification submitted by Cameron Medical Corp. for the device "PARA-VENT". The FDA issued a decision of Substantially Equivalent on September 17, 1979. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1979
Date Received
August 6, 1979
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 for product code BTC

  • K181424 — PeDIA (September 25, 2018)
  • K940220 — REBREATHER BAGS (May 27, 1994)
  • K932584 — BREATHING BAGS (July 16, 1993)
  • K932581 — BREATHING BAGS (July 16, 1993)
  • K932496 — PRECISION MED PRODUCTS, LTD. BREATHING BAGS (July 16, 1993)
  • K932191 — BREATHING BAGS (July 2, 1993)
  • K894906 — ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER (September 18, 1989)
  • K880680 — KING SYSTEMS, BREATHING BAG (March 3, 1988)
  • K864822 — VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (January 15, 1987)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)

FDA data resources