The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Tecnol Secure-all Tube Holder.
| Device ID | K891178 |
| 510k Number | K891178 |
| Device Name: | TECNOL SECURE-ALL TUBE HOLDER |
| Classification | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| 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 | EYZ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-06 |
| Decision Date | 1989-05-23 |