The following data is part of a premarket notification filed by Lerner Laboratories, Inc. with the FDA for Xylene Substitute Montant.
| Device ID | K854083 |
| 510k Number | K854083 |
| Device Name: | XYLENE SUBSTITUTE MONTANT |
| Classification | Agent, Clearing |
| Applicant | LERNER LABORATORIES, INC. 17 JAMES ST. New Haven, CT 06513 |
| Contact | Susan E Segal |
| Correspondent | Susan E Segal LERNER LABORATORIES, INC. 17 JAMES ST. New Haven, CT 06513 |
| Product Code | KEM |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-07 |
| Decision Date | 1985-10-22 |