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FDA 510(k)

TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES

K-Number: K940903 · 1994-04-14

ApplicantMedical Insights, Inc.
Decision Date1994-04-14
Product CodeKBM
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Medical Insights, Inc.. It received FDA 510(k) clearance on 1994-04-14 under 510(k) number K940903. The device is classified under product code KBM. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES?

TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES is a medical device that received FDA 510(k) clearance on 1994-04-14. The listed applicant is Medical Insights, Inc.. The 510(k) number is K940903.

When did TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES receive FDA 510(k) clearance?

TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES received FDA 510(k) clearance on 1994-04-14, under 510(k) number K940903.

Who is the listed applicant for TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES?

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

What is the FDA product code for TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES?

The FDA product code for TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES is KBM.

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Other records listing Medical Insights, 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.

K940904KITTNER DISSECTOR/PEANUT/CHERRY/STICK/TRIANGLE SPONGE/GAUZE ROSEBUDK940901NON-WOVEN SPONGEK924958BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY

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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