The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for S & C Hydro Vinyl Polysiloxane Impression Material.
Device ID | K012767 |
510k Number | K012767 |
Device Name: | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL |
Classification | Material, Impression |
Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STRABE 5 Elmshorn, DE D-25335 |
Contact | Christian Bottcher |
Correspondent | Christian Bottcher S & C POLYMER GMBH ROBERT-BOSCH-STRABE 5 Elmshorn, DE D-25335 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-17 |
Decision Date | 2001-11-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
EHAR70837521 | K012767 | 000 |
D6620708547782 | K012767 | 000 |
EHAR70837011 | K012767 | 000 |
EHAR70837021 | K012767 | 000 |
EHAR70837111 | K012767 | 000 |
EHAR70837121 | K012767 | 000 |
EHAR70837211 | K012767 | 000 |
EHAR70837221 | K012767 | 000 |
EHAR70837311 | K012767 | 000 |
EHAR70837321 | K012767 | 000 |
EHAR70837331 | K012767 | 000 |
EHAR70837401 | K012767 | 000 |
EHAR70837411 | K012767 | 000 |
EHAR70837421 | K012767 | 000 |
EHAR70837511 | K012767 | 000 |
D6620708547602 | K012767 | 000 |