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FDA 510(k)

SPENCO SILICONE GEL SHEET

K-Number: K981902 · 1998-06-25

ApplicantSpenco Medical Corp.
Decision Date1998-06-25
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPENCO SILICONE GEL SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Spenco Medical Corp.. It received FDA 510(k) clearance on 1998-06-25 under 510(k) number K981902. 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 SPENCO SILICONE GEL SHEET?

SPENCO SILICONE GEL SHEET is a medical device that received FDA 510(k) clearance on 1998-06-25. The listed applicant is Spenco Medical Corp.. The 510(k) number is K981902.

When did SPENCO SILICONE GEL SHEET receive FDA 510(k) clearance?

SPENCO SILICONE GEL SHEET received FDA 510(k) clearance on 1998-06-25, under 510(k) number K981902.

Who is the listed applicant for SPENCO SILICONE GEL SHEET?

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

What is the FDA product code for SPENCO SILICONE GEL SHEET?

The FDA product code for SPENCO SILICONE GEL SHEET is MDA.

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Other records listing Spenco Medical 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.

K9222282ND SKIN STERILE ADHESIVE STRIPK9115502ND SKIN MOIST BURN PADS WITH ALOEK910927SPENCIO SKIN GUARD KITK896533SPENCO BREAST FORMSK8948982ND SKIN NON-STICK MOIST BURN PADSK820906SPENCO CRYOPRESS

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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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