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FDA 510(k)

NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM

K-Number: K951119 · 1995-06-13

ApplicantAmerican Hydro-Surgical Instruments, Inc.
Decision Date1995-06-13
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Hydro-Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1995-06-13 under 510(k) number K951119. 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 NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM?

NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-13. The listed applicant is American Hydro-Surgical Instruments, Inc.. The 510(k) number is K951119.

When did NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM receive FDA 510(k) clearance?

NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM received FDA 510(k) clearance on 1995-06-13, under 510(k) number K951119.

Who is the listed applicant for NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM?

The FDA 510(k) record lists American Hydro-Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM?

The FDA product code for NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM is GCX.

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Other records listing American Hydro-Surgical Instruments, 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.

K953574NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZERK953481NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZERK952070NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANSK946380NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)K951300NEZHAT-DORSEY THERMAL RETENTION SYSTEMK950499NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS

View all 18 devices →

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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