The following data is part of a premarket notification filed by Collimare, Llc with the FDA for Collimare Collimator Family.
| Device ID | K073124 |
| 510k Number | K073124 |
| Device Name: | COLLIMARE COLLIMATOR FAMILY |
| Classification | Collimator, Automatic, Radiographic |
| Applicant | COLLIMARE, LLC 13406 W 60TH PL Arvada, CO 80004 |
| Contact | Howard C Thomas |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IZW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-06 |
| Decision Date | 2007-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862005000368 | K073124 | 000 |
| 00862005000351 | K073124 | 000 |
| 00862005000344 | K073124 | 000 |
| 00862005000337 | K073124 | 000 |
| 00862005000320 | K073124 | 000 |
| 00862005000313 | K073124 | 000 |
| 00862005000306 | K073124 | 000 |