The following data is part of a premarket notification filed by Rochester Electro Medical, Inc. with the FDA for Ultrasharp Concentric Needles.
| Device ID | K080914 |
| 510k Number | K080914 |
| Device Name: | ULTRASHARP CONCENTRIC NEEDLES |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | ROCHESTER ELECTRO MEDICAL, INC. 4212 CYPRESS GULCH DRIVE Lutz, FL 33559 |
| Contact | Charles C Berkins |
| Correspondent | Charles C Berkins ROCHESTER ELECTRO MEDICAL, INC. 4212 CYPRESS GULCH DRIVE Lutz, FL 33559 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-01 |
| Decision Date | 2008-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849593009812 | K080914 | 000 |
| 00849593009799 | K080914 | 000 |
| 00849593009775 | K080914 | 000 |
| 00849593009751 | K080914 | 000 |
| 00849593009713 | K080914 | 000 |
| 00849593009690 | K080914 | 000 |
| 00849593009652 | K080914 | 000 |