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FDA 510(k)

MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST

K-Number: K933811 · 1994-05-12

ApplicantPitt Enterprises (Silicone) , Ltd.
Decision Date1994-05-12
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST is the device name listed in this FDA 510(k) record. The listed applicant is Pitt Enterprises (Silicone) , Ltd.. It received FDA 510(k) clearance on 1994-05-12 under 510(k) number K933811. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST?

MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST is a medical device that received FDA 510(k) clearance on 1994-05-12. The listed applicant is Pitt Enterprises (Silicone) , Ltd.. The 510(k) number is K933811.

When did MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST receive FDA 510(k) clearance?

MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST received FDA 510(k) clearance on 1994-05-12, under 510(k) number K933811.

Who is the listed applicant for MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST?

The FDA 510(k) record lists Pitt Enterprises (Silicone) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST?

The FDA product code for MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST is MDA.

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Related Devices (Code: MDA)

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.

K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLCK053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K040307HANSON SCAR ADEHanson Medical, Inc.

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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