The following data is part of a premarket notification filed by Fred Haer Company, Inc. with the FDA for Microtable System.
| Device ID | K132611 |
| 510k Number | K132611 |
| Device Name: | MICROTABLE SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | FRED HAER COMPANY, INC. 1201 MAIN STREET Bowdoin, ME 04287 |
| Contact | Keri Seitz |
| Correspondent | Keri Seitz FRED HAER COMPANY, INC. 1201 MAIN STREET Bowdoin, ME 04287 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-20 |
| Decision Date | 2014-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00873263006436 | K132611 | 000 |
| 10873263006457 | K132611 | 000 |
| 10873263006440 | K132611 | 000 |
| 00196852534531 | K132611 | 000 |