The following data is part of a premarket notification filed by Coltene/whaledent Gmbh & Co. Kg with the FDA for Stay-put Impregnated.
| Device ID | K041023 |
| 510k Number | K041023 |
| Device Name: | STAY-PUT IMPREGNATED |
| Classification | Cord, Retraction |
| Applicant | COLTENE/WHALEDENT GMBH & CO. KG CARE OF HENRY J. VOGELSTEIN 1349 LEXINGTON AVE. New York, NY 10128 |
| Contact | Henry J Vogelstein |
| Correspondent | Henry J Vogelstein COLTENE/WHALEDENT GMBH & CO. KG CARE OF HENRY J. VOGELSTEIN 1349 LEXINGTON AVE. New York, NY 10128 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-04-20 |
| Decision Date | 2004-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E1655230020 | K041023 | 000 |
| E1655110010 | K041023 | 000 |
| E1655110020 | K041023 | 000 |
| E1655110030 | K041023 | 000 |
| E1655210000 | K041023 | 000 |
| E1655210010 | K041023 | 000 |
| E1655210020 | K041023 | 000 |
| E1655210030 | K041023 | 000 |
| E1655230000 | K041023 | 000 |
| E1655230010 | K041023 | 000 |
| E1655110000 | K041023 | 000 |