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FDA 510(k)

BIOPSY NEEDLES & TRAYS

K-Number: K813338 · 1982-01-28

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1982-01-28
Product CodeFSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOPSY NEEDLES & TRAYS 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 1982-01-28 under 510(k) number K813338. The device is classified under product code FSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY NEEDLES & TRAYS?

BIOPSY NEEDLES & TRAYS is a medical device that received FDA 510(k) clearance on 1982-01-28. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K813338.

When did BIOPSY NEEDLES & TRAYS receive FDA 510(k) clearance?

BIOPSY NEEDLES & TRAYS received FDA 510(k) clearance on 1982-01-28, under 510(k) number K813338.

Who is the listed applicant for BIOPSY NEEDLES & TRAYS?

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 BIOPSY NEEDLES & TRAYS?

The FDA product code for BIOPSY NEEDLES & TRAYS is FSH.

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Other records listing American Pharmaseal Div. Ahsc as applicant

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Related Devices (Code: FSH)

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.

K884876S 4 INSTRUMENT STANDCarl Zeiss, Inc.K883578S 21 INSTRUMENT STANDCarl Zeiss, Inc.K821921STAND, SURG. INSTRUMENT & DRESSINGEmerson-Sack-Warner Corp.K813337SKINNY CHIBA NEEDLE & TRAYAmerican Pharmaseal Div. AhscK813335PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAYAmerican Pharmaseal Div. AhscK780759MODEL 902 STANDApplied Medical Research

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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