The following data is part of a premarket notification filed by Med-tec,inc. with the FDA for Moldcare Head & Neck Cushion, Model # Mt-acl-14242.
| Device ID | K982624 |
| 510k Number | K982624 |
| Device Name: | MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 |
| Classification | Accelerator, Linear, Medical |
| Applicant | MED-TEC,INC. 1401 8TH ST. S.E. P.O. BOX 320 Orange City, IA 51041 |
| Contact | Donald F Riibe |
| Correspondent | Donald F Riibe MED-TEC,INC. 1401 8TH ST. S.E. P.O. BOX 320 Orange City, IA 51041 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-28 |
| Decision Date | 1998-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439104408 | K982624 | 000 |
| 00841439104392 | K982624 | 000 |