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FDA 510(k)

PNEUMO DRAIN T.M. RECORDER #PD-800

K-Number: K821160 · 1982-05-27

ApplicantSugen Industries, Inc.
Decision Date1982-05-27
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PNEUMO DRAIN T.M. RECORDER #PD-800 is the device name listed in this FDA 510(k) record. The listed applicant is Sugen Industries, Inc.. It received FDA 510(k) clearance on 1982-05-27 under 510(k) number K821160. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEUMO DRAIN T.M. RECORDER #PD-800?

PNEUMO DRAIN T.M. RECORDER #PD-800 is a medical device that received FDA 510(k) clearance on 1982-05-27. The listed applicant is Sugen Industries, Inc.. The 510(k) number is K821160.

When did PNEUMO DRAIN T.M. RECORDER #PD-800 receive FDA 510(k) clearance?

PNEUMO DRAIN T.M. RECORDER #PD-800 received FDA 510(k) clearance on 1982-05-27, under 510(k) number K821160.

Who is the listed applicant for PNEUMO DRAIN T.M. RECORDER #PD-800?

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

What is the FDA product code for PNEUMO DRAIN T.M. RECORDER #PD-800?

The FDA product code for PNEUMO DRAIN T.M. RECORDER #PD-800 is GCX.

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Related Devices (Code: GCX)

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.

K042454STRYKER CASSETTE PUMPStryker EndoscopyK992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMCircon Corp.K972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.K971022CHASE SUCKERChase Medical, Inc.K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health

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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