The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Intra-oral Thermoplastic Shield.
| Device ID | K962622 |
| 510k Number | K962622 |
| Device Name: | INTRA-ORAL THERMOPLASTIC SHIELD |
| Classification | Shield, Protective, Personnel |
| Applicant | MEDTEC, INC. 1401 8TH ST., S.E. P.O. BOX 320 Orange City, IA 51041 -0320 |
| Contact | Donald F Riibe |
| Correspondent | Donald F Riibe MEDTEC, INC. 1401 8TH ST., S.E. P.O. BOX 320 Orange City, IA 51041 -0320 |
| Product Code | KPY |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-05 |
| Decision Date | 1996-10-01 |