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FDA 510(k)

SPECIMEN SET

K-Number: K802340 · 1980-10-10

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1980-10-10
Product CodeFMH
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

SPECIMEN SET is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802340. The device is classified under product code FMH. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECIMEN SET?

SPECIMEN SET is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K802340.

When did SPECIMEN SET receive FDA 510(k) clearance?

SPECIMEN SET received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802340.

Who is the listed applicant for SPECIMEN SET?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECIMEN SET?

The FDA product code for SPECIMEN SET is FMH.

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Other records listing American Pharmaseal Div. Ahsc 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.

K874022PHARMASEAL WOUND IRRIGATION DEVICEK874517PHARMASEAL RUBBER URETHRAL CATHETERK874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERK873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVEK872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEMK872917JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER

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Related Devices (Code: FMH)

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.

K900983TRI-TECH URINE SPECIMEN KITTri-Tech, Inc.K823763VARIOUS-SPECIMEN COLLECTORSCordis Corp.K820180CALCULI FILTER CUPOmnimedicalK812933LANCER SPECIMEN CONTAINERSherwood Medical Co.K802002URINE SPECIMEN CONTAINER #'S 1013-1016Pollak (Intl.), Ltd.K800947MIDSTREAM COLLECTION KITSage 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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