The following data is part of a premarket notification filed by Tecnol Medical Products, Inc. with the FDA for System 2 Zippered Body Holder, Small/medium 24453-010,24453-020,24453-030.
| Device ID | K963557 |
| 510k Number | K963557 |
| Device Name: | SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030 |
| Classification | Restraint, Protective |
| Applicant | TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Contact | Ruth L Jones |
| Correspondent | Ruth L Jones TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-05 |
| Decision Date | 1996-11-21 |