The following data is part of a premarket notification filed by Amertek Medical, Inc. with the FDA for Ameritek Sure-point Hdr Needle Template.
| Device ID | K031273 |
| 510k Number | K031273 |
| Device Name: | AMERITEK SURE-POINT HDR NEEDLE TEMPLATE |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | AMERTEK MEDICAL, INC. 2655 N. OCEAN DR. #405 Singer Island, FL 33404 |
| Contact | Greg Wiita |
| Correspondent | Greg Wiita AMERTEK MEDICAL, INC. 2655 N. OCEAN DR. #405 Singer Island, FL 33404 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-22 |
| Decision Date | 2003-07-15 |
| Summary: | summary |