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FDA 510(k)

ESPREE', BREATHING BAG

K-Number: K821309 · 1982-05-21

ApplicantEsp Plastics, Inc.
Decision Date1982-05-21
Product CodeBTC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ESPREE', BREATHING BAG is the device name listed in this FDA 510(k) record. The listed applicant is Esp Plastics, Inc.. It received FDA 510(k) clearance on 1982-05-21 under 510(k) number K821309. The device is classified under product code BTC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESPREE', BREATHING BAG?

ESPREE', BREATHING BAG is a medical device that received FDA 510(k) clearance on 1982-05-21. The listed applicant is Esp Plastics, Inc.. The 510(k) number is K821309.

When did ESPREE', BREATHING BAG receive FDA 510(k) clearance?

ESPREE', BREATHING BAG received FDA 510(k) clearance on 1982-05-21, under 510(k) number K821309.

Who is the listed applicant for ESPREE', BREATHING BAG?

The FDA 510(k) record lists Esp Plastics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESPREE', BREATHING BAG?

The FDA product code for ESPREE', BREATHING BAG is BTC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Esp Plastics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K821310ESPREE' ANESTHESIA BACTERIAL FILTERK821311ESPREE' BREATHING CIRCUIT (W/ACCESSK821308ESPREE' GUEDEL ESPREE BERMAN AIRWAY

Related Devices (Code: BTC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181424PeDIAPedia, LLCK940220REBREATHER BAGSZefon Medical ProductsK932584BREATHING BAGSMerit Medical Systems, Inc.K932496PRECISION MED PRODUCTS, LTD. BREATHING BAGSPrecision Med Products, Ltd.K932581BREATHING BAGSMed-Plastics Intl., Inc.K932191BREATHING BAGSLife Shield Healthcare Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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