The following data is part of a premarket notification filed by Numed Technologies, Inc. with the FDA for Numed Disposable Att. Numed Handle Lap. Inst..
| Device ID | K931501 |
| 510k Number | K931501 |
| Device Name: | NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST. |
| Classification | Laparoscope, Gynecologic (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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-25 |
| Decision Date | 1994-01-11 |