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FDA 510(k)

SPECTRUM DESIGNS SPECTRAGEL

K-Number: K970702 · 1997-05-12

ApplicantSpectrum Designs, Inc.
Decision Date1997-05-12
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRUM DESIGNS SPECTRAGEL is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Designs, Inc.. It received FDA 510(k) clearance on 1997-05-12 under 510(k) number K970702. 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 SPECTRUM DESIGNS SPECTRAGEL?

SPECTRUM DESIGNS SPECTRAGEL is a medical device that received FDA 510(k) clearance on 1997-05-12. The listed applicant is Spectrum Designs, Inc.. The 510(k) number is K970702.

When did SPECTRUM DESIGNS SPECTRAGEL receive FDA 510(k) clearance?

SPECTRUM DESIGNS SPECTRAGEL received FDA 510(k) clearance on 1997-05-12, under 510(k) number K970702.

Who is the listed applicant for SPECTRUM DESIGNS SPECTRAGEL?

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

What is the FDA product code for SPECTRUM DESIGNS SPECTRAGEL?

The FDA product code for SPECTRUM DESIGNS SPECTRAGEL is MDA.

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Other records listing Spectrum Designs, 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.

K992522SPECTRUM DESIGNS SPECTRAGELK982688SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCKK980445SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANTK980463SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANTK980444SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANTK980446SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT

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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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