The following data is part of a premarket notification filed by Worldwide Medical Technologies, Llc with the FDA for Worldwide Medical Technologies Introducer Needle.
| Device ID | K981889 |
| 510k Number | K981889 |
| Device Name: | WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE |
| Classification | Biopsy Needle |
| 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 | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-29 |
| Decision Date | 1998-07-31 |