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FDA 510(k)

MEDCARE YANKAUER SUCTION DEVICE

K-Number: K954869 · 1996-01-19

ApplicantMedcare Custom Packaging, Inc.
Decision Date1996-01-19
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDCARE YANKAUER SUCTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Custom Packaging, Inc.. It received FDA 510(k) clearance on 1996-01-19 under 510(k) number K954869. 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 MEDCARE YANKAUER SUCTION DEVICE?

MEDCARE YANKAUER SUCTION DEVICE is a medical device that received FDA 510(k) clearance on 1996-01-19. The listed applicant is Medcare Custom Packaging, Inc.. The 510(k) number is K954869.

When did MEDCARE YANKAUER SUCTION DEVICE receive FDA 510(k) clearance?

MEDCARE YANKAUER SUCTION DEVICE received FDA 510(k) clearance on 1996-01-19, under 510(k) number K954869.

Who is the listed applicant for MEDCARE YANKAUER SUCTION DEVICE?

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

What is the FDA product code for MEDCARE YANKAUER SUCTION DEVICE?

The FDA product code for MEDCARE YANKAUER SUCTION DEVICE is GCX.

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Other records listing Medcare Custom Packaging, 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.

K954442STERILE ISOTONIC SALINE & STERILE WATERK952759TOWEL PACKK950390URETHRAL CATHETERIZATION TRAYK943661STERILE PHYSIOLOGICAL SALINE/STERILE WATERK951149SINGLE USE INSTRUMENT TRAYK934732PELVIC EXAM TRAY

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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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