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FDA 510(k)

MACLEAN-FOGG, DISP. BASE MOLD

K-Number: K831900 · 1983-07-28

ApplicantPolymer Technology Corp.
Decision Date1983-07-28
Product CodeKER
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

MACLEAN-FOGG, DISP. BASE MOLD is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Corp.. It received FDA 510(k) clearance on 1983-07-28 under 510(k) number K831900. The device is classified under product code KER. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACLEAN-FOGG, DISP. BASE MOLD?

MACLEAN-FOGG, DISP. BASE MOLD is a medical device that received FDA 510(k) clearance on 1983-07-28. The listed applicant is Polymer Technology Corp.. The 510(k) number is K831900.

When did MACLEAN-FOGG, DISP. BASE MOLD receive FDA 510(k) clearance?

MACLEAN-FOGG, DISP. BASE MOLD received FDA 510(k) clearance on 1983-07-28, under 510(k) number K831900.

Who is the listed applicant for MACLEAN-FOGG, DISP. BASE MOLD?

The FDA 510(k) record lists Polymer Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MACLEAN-FOGG, DISP. BASE MOLD?

The FDA product code for MACLEAN-FOGG, DISP. BASE MOLD is KER.

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Other records listing Polymer Technology Corp. 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.

K011945RIGID GAS PERMEABLE CONTACT LENS SOLUTIONK980133BAUSCH & LOMB WETTING AND SOAKING SOLUTIONK974466BOSTON ADVANCE CLEANERK973217BOSTON LIQUID ENZYMATIC CLEANERK970698BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENSK951552BOSTON CONTACT LENS CASE

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Related Devices (Code: KER)

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.

K831922EMBEDDING RINGPolymer Technology Corp.K831333EMBEDDING RINGSSurgipath Medical Industries, Inc.K831335DISPOSABLE BASE MOLDSurgipath Medical Industries, Inc.K772149LANCER BIOPSY HOLDERSherwood Medical Industries

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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