The following data is part of a premarket notification filed by Numed Technologies, Inc. with the FDA for Reusable Handle For Laparoscopic Inst. W/rotating.
| Device ID | K930571 |
| 510k Number | K930571 |
| Device Name: | REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING |
| Classification | Coagulator, Culdoscopic (and Accessories) |
| Applicant | NUMED TECHNOLOGIES, INC. 5755 GRANGER RD. Independence, OH 44131 |
| Contact | Jan Lewandowski |
| Correspondent | Jan Lewandowski NUMED TECHNOLOGIES, INC. 5755 GRANGER RD. Independence, OH 44131 |
| Product Code | HFI |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-04 |
| Decision Date | 1994-02-01 |