The following data is part of a premarket notification filed by Worldwide Medical Technologies, Llc with the FDA for Worldwide Medical Technologies I Type Needle.
| Device ID | K980068 |
| 510k Number | K980068 |
| Device Name: | WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE |
| Classification | Instrument, Biopsy |
| 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 | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-08 |
| Decision Date | 1998-01-23 |