The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Flouroshield Radiation Reduction Glove.
| Device ID | K893093 |
| 510k Number | K893093 |
| Device Name: | FLOUROSHIELD RADIATION REDUCTION GLOVE |
| Classification | Patient Examination Glove, Specialty |
| Applicant | ACUFEX MICROSURGICAL, INC. 575 UNIVERSITY AVE. Norwood, MA 02062 |
| Contact | Richard E Franko |
| Correspondent | Richard E Franko ACUFEX MICROSURGICAL, INC. 575 UNIVERSITY AVE. Norwood, MA 02062 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1990-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857164008041 | K893093 | 000 |
| 00857164008034 | K893093 | 000 |
| 00857164008027 | K893093 | 000 |
| 00857164008010 | K893093 | 000 |
| 00857164008003 | K893093 | 000 |