The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Tecnol Catheter Leg Strap.
| Device ID | K882641 |
| 510k Number | K882641 |
| Device Name: | TECNOL CATHETER LEG STRAP |
| Classification | Accessories, Catheter, G-u |
| Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Contact | Leona M Hammel |
| Correspondent | Leona M Hammel TECNOL NEW JERSEY WOUND CARE, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-27 |
| Decision Date | 1988-07-12 |