ESPREE', BREATHING BAG— 510(k) K821309

Substantially Equivalent

Esp Plastics, Inc.

FDA 510(k) clearance K821309 for ESPREE', BREATHING BAG, Substantially Equivalent on 1982-05-21. Applicant: Esp Plastics, Inc.. Device class: 1.

Clearance details

Applicant: Esp Plastics, Inc.
Product code: Code BTC
Device class: Class 1
Regulation: 21 CFR 868.5320
Advisory panel: Anesthesiology
Date received: 1982-05-04
Decision date: 1982-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTC

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K932496 — PRECISION MED PRODUCTS, LTD. BREATHING BAGS1993-07-16
K932581 — BREATHING BAGS1993-07-16
K932584 — BREATHING BAGS1993-07-16

More clearances from Esp Plastics, Inc.

K821310 — ESPREE' ANESTHESIA BACTERIAL FILTER1982-06-11
K821308 — ESPREE' GUEDEL ESPREE BERMAN AIRWAY1982-05-21
K821311 — ESPREE' BREATHING CIRCUIT (W/ACCESS1982-05-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.