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FDA 510(k)

KOGAN ENDOSPECULUM 9-1/2

K-Number: K842111 · 1984-06-19

Decision Date1984-06-19
Product CodeHTZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KOGAN ENDOSPECULUM 9-1/2 is the device name listed in this FDA 510(k) record. The listed applicant is J. Sklar Mfg. Co., Inc.. It received FDA 510(k) clearance on 1984-06-19 under 510(k) number K842111. The device is classified under product code HTZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOGAN ENDOSPECULUM 9-1/2?

KOGAN ENDOSPECULUM 9-1/2 is a medical device that received FDA 510(k) clearance on 1984-06-19. The listed applicant is J. Sklar Mfg. Co., Inc.. The 510(k) number is K842111.

When did KOGAN ENDOSPECULUM 9-1/2 receive FDA 510(k) clearance?

KOGAN ENDOSPECULUM 9-1/2 received FDA 510(k) clearance on 1984-06-19, under 510(k) number K842111.

Who is the listed applicant for KOGAN ENDOSPECULUM 9-1/2?

The FDA 510(k) record lists J. Sklar Mfg. Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KOGAN ENDOSPECULUM 9-1/2?

The FDA product code for KOGAN ENDOSPECULUM 9-1/2 is HTZ.

Related Clinical Trials

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.

Other records listing J. Sklar Mfg. Co., 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.

View all 18 devices →

Related Devices (Code: HTZ)

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.

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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