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FDA 510(k)

VINYL SILICONE ELASTOMER MATERIAL

K-Number: K901990 · 1990-09-14

ApplicantCrown Delta Corp.
Decision Date1990-09-14
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VINYL SILICONE ELASTOMER MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Crown Delta Corp.. It received FDA 510(k) clearance on 1990-09-14 under 510(k) number K901990. 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 VINYL SILICONE ELASTOMER MATERIAL?

VINYL SILICONE ELASTOMER MATERIAL is a medical device that received FDA 510(k) clearance on 1990-09-14. The listed applicant is Crown Delta Corp.. The 510(k) number is K901990.

When did VINYL SILICONE ELASTOMER MATERIAL receive FDA 510(k) clearance?

VINYL SILICONE ELASTOMER MATERIAL received FDA 510(k) clearance on 1990-09-14, under 510(k) number K901990.

Who is the listed applicant for VINYL SILICONE ELASTOMER MATERIAL?

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

What is the FDA product code for VINYL SILICONE ELASTOMER MATERIAL?

The FDA product code for VINYL SILICONE ELASTOMER MATERIAL is MDA.

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Other records listing Crown Delta 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.

K122974TRYOUT-VPS HOLDING PASTEK041028CROWN DELTA HYDROPHILIC IMPRESSION MATERIALK955288HEARING AID IMPRESSION MATERIALK940132PODIATRIC MATERIALK930248VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEMK926150VINYL ADDITION SILICONE SYSTEM

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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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