The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Fluoro-shield Radiation Reduction Gloves.
| Device ID | K920620 |
| 510k Number | K920620 |
| Device Name: | FLUORO-SHIELD RADIATION REDUCTION GLOVES |
| Classification | Patient Examination Glove, Specialty |
| Applicant | ACUFEX MICROSURGICAL, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Ivan S Placko |
| Correspondent | Ivan S Placko ACUFEX MICROSURGICAL, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-11 |
| Decision Date | 1993-06-22 |