The following data is part of a premarket notification filed by Glasspan, Inc. with the FDA for Flexible Ceramic Ropes And Tapes For Bonding.
| Device ID | K922673 |
| 510k Number | K922673 |
| Device Name: | FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING |
| Classification | Splint, Endodontic Stabilizing |
| Applicant | GLASSPAN, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 |
| Contact | Edward L Korwek |
| Correspondent | Edward L Korwek GLASSPAN, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 |
| Product Code | ELS |
| CFR Regulation Number | 872.3890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-04 |
| Decision Date | 1994-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00723896011737 | K922673 | 000 |