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FDA 510(k)

DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET

K-Number: K924837 · 1993-10-12

ApplicantAssociated Ent., Inc.
Decision Date1993-10-12
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET is the device name listed in this FDA 510(k) record. The listed applicant is Associated Ent., Inc.. It received FDA 510(k) clearance on 1993-10-12 under 510(k) number K924837. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET?

DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET is a medical device that received FDA 510(k) clearance on 1993-10-12. The listed applicant is Associated Ent., Inc.. The 510(k) number is K924837.

When did DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET receive FDA 510(k) clearance?

DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET received FDA 510(k) clearance on 1993-10-12, under 510(k) number K924837.

Who is the listed applicant for DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET?

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

What is the FDA product code for DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET?

The FDA product code for DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET is LDQ.

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Other records listing Associated Ent., 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.

K915636GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.K891835BUD BRAND PATIENT EXAMINATION GLOVES (VINYL)K891836BUD BRAND PATIENT EXAMINATION GLOVES (LATEX)

Related Devices (Code: LDQ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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