The following data is part of a premarket notification filed by Dravon Medical, Inc. with the FDA for Am-100 I/a Ampac.
| Device ID | K860770 |
| 510k Number | K860770 |
| Device Name: | AM-100 I/A AMPAC |
| Classification | Unit, Phacofragmentation |
| Applicant | DRAVON MEDICAL, INC. P.O. BOX 69, 11465 S.E. HIGHWAY 212 Clackamas, OR 97015 |
| Contact | Madalyn C Duncan |
| Correspondent | Madalyn C Duncan DRAVON MEDICAL, INC. P.O. BOX 69, 11465 S.E. HIGHWAY 212 Clackamas, OR 97015 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-03 |
| Decision Date | 1986-04-21 |