The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for L(3), Lysnig Lead Latex Radiation Glove(r).
| Device ID | K896076 |
| 510k Number | K896076 |
| Device Name: | L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R) |
| Classification | Patient Examination Glove, Specialty |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Contact | Ronald D Arkin |
| Correspondent | Ronald D Arkin ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-19 |
| Decision Date | 1990-01-04 |