The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Tecnol Compression Knee Dressing.
Device ID | K873368 |
510k Number | K873368 |
Device Name: | TECNOL COMPRESSION KNEE DRESSING |
Classification | Legging, Compression, Non-inflatable |
Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 7450 WHITEHALL ST. Ft. Worth, TX 76012 |
Contact | David Archer |
Correspondent | David Archer TECNOL NEW JERSEY WOUND CARE, INC. 7450 WHITEHALL ST. Ft. Worth, TX 76012 |
Product Code | LLK |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-21 |
Decision Date | 1987-12-11 |