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510(k) K800155

DISPOSAL LITER BREATHING BAG by Dryden Corp. — Product Code BTC

K800155 is an FDA 510(k) premarket notification submitted by Dryden Corp. for the device "DISPOSAL LITER BREATHING BAG". The FDA issued a decision of Substantially Equivalent on February 21, 1980. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320. Dryden Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1980
Date Received
January 23, 1980
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 Dryden Corp.

  • K880923 — PATIENT VENTILATOR ISOLATOR (September 6, 1988)
  • K880769 — BREATHING CIRCUIT W/HEATED WIRE (August 24, 1988)
  • K882285 — NONREBREATHING CIRCUIT (August 16, 1988)
  • K873928 — UNIVERSAL TOURNIQUET (October 23, 1987)
  • K873927 — REUSEABLE BREATHING TUBES (October 20, 1987)
  • K870859 — BAG-TAIL BLEED VALVE (August 3, 1987)
  • K871386 — BREATHING CIRCUIT (May 29, 1987)
  • K870858 — BADGWELL SAMPLING CATHETER (May 14, 1987)
  • K861540 — DISPOSABLE BERMAN AND GUEDEL AIRWAYS (May 2, 1986)
  • K850644 — NASOPHARYNGEAL AIRWAY-ROBERTAZZI (March 21, 1985)

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