The following data is part of a premarket notification filed by Vascutech, Inc. with the FDA for Sterile Lemaitre Glow 'n Tell Tape.
| Device ID | K932184 |
| 510k Number | K932184 |
| Device Name: | STERILE LEMAITRE GLOW 'N TELL TAPE |
| Classification | Assembly, Thigh/knee/shank/ankle/foot, External |
| Applicant | VASCUTECH, INC. 790 TURNPIKE ST. North Andover, MA 01845 |
| Contact | George Lemaitre |
| Correspondent | George Lemaitre VASCUTECH, INC. 790 TURNPIKE ST. North Andover, MA 01845 |
| Product Code | KFX |
| CFR Regulation Number | 890.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-05 |
| Decision Date | 1993-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663100408 | K932184 | 000 |
| 00840663100392 | K932184 | 000 |
| 00840663100385 | K932184 | 000 |
| 00840663100378 | K932184 | 000 |
| 00840663100361 | K932184 | 000 |
| 00840663100354 | K932184 | 000 |
| 00840663100347 | K932184 | 000 |
| 00840663100330 | K932184 | 000 |
| 00840663100323 | K932184 | 000 |