The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Imtec Bone Collector System.
| Device ID | K973248 |
| 510k Number | K973248 |
| Device Name: | IMTEC BONE COLLECTOR SYSTEM |
| Classification | Evacuator, Oral Cavity |
| Applicant | IMTEC CORP. 2401 N. COMMERCE P.O. BOXC 1562 Ardmore, OK 73402 |
| Contact | M.k. Patterson |
| Correspondent | M.k. Patterson IMTEC CORP. 2401 N. COMMERCE P.O. BOXC 1562 Ardmore, OK 73402 |
| Product Code | EHZ |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-29 |
| Decision Date | 1997-11-19 |
| Summary: | summary |