FDA 510(k)

S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL

K-Number: K012767 · 2001-11-01

Decision Date2001-11-01

Product CodeELW

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is S & C Polymer GmbH. It received FDA 510(k) clearance on 2001-11-01 under 510(k) number K012767. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL?

S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 2001-11-01. The listed applicant is S & C Polymer GmbH. The 510(k) number is K012767.

When did S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL receive FDA 510(k) clearance?

S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL received FDA 510(k) clearance on 2001-11-01, under 510(k) number K012767.

Who is the listed applicant for S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL?

The FDA 510(k) record lists S & C Polymer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL?

The FDA product code for S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL is ELW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.