The following data is part of a premarket notification filed by Advanced Instruments, Inc. with the FDA for Advanced Micro-osmometer Model 3300.
| Device ID | K962056 |
| 510k Number | K962056 |
| Device Name: | ADVANCED MICRO-OSMOMETER MODEL 3300 |
| Classification | Osmometer For Clinical Use |
| Applicant | ADVANCED INSTRUMENTS, INC. TWO TECHNOLOGY WAY Norwood, MA 02062 |
| Contact | Douglas Guerette |
| Correspondent | Douglas Guerette ADVANCED INSTRUMENTS, INC. TWO TECHNOLOGY WAY Norwood, MA 02062 |
| Product Code | JJM |
| CFR Regulation Number | 862.2730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-07-11 |