The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Tecnol Silk Strip.
| Device ID | K894205 |
| 510k Number | K894205 |
| Device Name: | TECNOL SILK STRIP |
| Classification | Strip, Adhesive, Closure, Skin |
| 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 | FPX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-19 |
| Decision Date | 1989-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00809958181515 | K894205 | 000 |
| 00809958181416 | K894205 | 000 |
| 00809958181218 | K894205 | 000 |
| 00809958000205 | K894205 | 000 |
| 00809958000199 | K894205 | 000 |
| 00809958000168 | K894205 | 000 |
| 00809958000137 | K894205 | 000 |
| 00809958000106 | K894205 | 000 |