The following data is part of a premarket notification filed by Worldwide Medical Technologies, Llc with the FDA for Worldwide Medical Technologies Needle Guide.
| Device ID | K981470 |
| 510k Number | K981470 |
| Device Name: | WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE |
| Classification | System, X-ray, Mammographic |
| Applicant | WORLDWIDE MEDICAL TECHNOLOGIES, LLC 125 MAIN ST., NORTH Woodbury, CT 06798 -0505 |
| Contact | Gary A Lamoureux |
| Correspondent | Gary A Lamoureux WORLDWIDE MEDICAL TECHNOLOGIES, LLC 125 MAIN ST., NORTH Woodbury, CT 06798 -0505 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-23 |
| Decision Date | 1998-06-19 |