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510(k) K821309

ESPREE', BREATHING BAG by Esp Plastics, Inc. — Product Code BTC

K821309 is an FDA 510(k) premarket notification submitted by Esp Plastics, Inc. for the device "ESPREE', BREATHING BAG". The FDA issued a decision of Substantially Equivalent on May 21, 1982. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320. Esp Plastics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1982
Date Received
May 4, 1982
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 Esp Plastics, Inc.

  • K821310 — ESPREE' ANESTHESIA BACTERIAL FILTER (June 11, 1982)
  • K821311 — ESPREE' BREATHING CIRCUIT (W/ACCESS (May 21, 1982)
  • K821308 — ESPREE' GUEDEL ESPREE BERMAN AIRWAY (May 21, 1982)

Other clearances for product code BTC

  • K181424 — PeDIA (September 25, 2018)
  • K940220 — REBREATHER BAGS (May 27, 1994)
  • K932581 — BREATHING BAGS (July 16, 1993)
  • K932496 — PRECISION MED PRODUCTS, LTD. BREATHING BAGS (July 16, 1993)
  • K932584 — 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)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)

FDA data resources