The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Tecnol Gaiters Product Number 47725-010.
| Device ID | K893702 |
| 510k Number | K893702 |
| Device Name: | TECNOL GAITERS PRODUCT NUMBER 47725-010 |
| Classification | Cover, Shoe, Operating-room |
| Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Contact | Leona Hammel |
| Correspondent | Leona Hammel TECNOL NEW JERSEY WOUND CARE, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Product Code | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-18 |
| Decision Date | 1989-06-23 |