The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Medilas H Rfid Laser Fibers.
| Device ID | K152591 |
| 510k Number | K152591 |
| Device Name: | Medilas H RFID Laser Fibers |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Dornier MedTech America, Inc. 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 |
| Contact | John Hoffer |
| Correspondent | John Hoffer Dornier MedTech America, Inc. 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-10 |
| Decision Date | 2015-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810116020317 | K152591 | 000 |
| 10810116023278 | K152591 | 000 |
| 04049958002724 | K152591 | 000 |