The following data is part of a premarket notification filed by Custom Medical Specialties, Inc. with the FDA for Custom Medical Suspension Strap.
| Device ID | K944988 |
| 510k Number | K944988 |
| Device Name: | CUSTOM MEDICAL SUSPENSION STRAP |
| Classification | Support, Breathing Tube |
| Applicant | CUSTOM MEDICAL SPECIALTIES, INC. 1445-P BROOKVILLE WAY Indianapolis, IN 46239 |
| Contact | Mike Thomas |
| Correspondent | Mike Thomas CUSTOM MEDICAL SPECIALTIES, INC. 1445-P BROOKVILLE WAY Indianapolis, IN 46239 |
| Product Code | JAY |
| CFR Regulation Number | 868.5280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-12 |
| Decision Date | 1995-01-27 |