The following data is part of a premarket notification filed by Worldwide Medical Technologies, Llc with the FDA for Worldwide Medical Technologies Intracervical Block Needle, Model Tbd.
| Device ID | K982097 |
| 510k Number | K982097 |
| Device Name: | WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WORLDWIDE MEDICAL TECHNOLOGIES, LLC 125 MAIN ST., NORTH Woodbury, CT 06798 -0505 |
| Contact | Gary Lamoureux |
| Correspondent | Gary Lamoureux WORLDWIDE MEDICAL TECHNOLOGIES, LLC 125 MAIN ST., NORTH Woodbury, CT 06798 -0505 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-15 |
| Decision Date | 1998-06-25 |