The following data is part of a premarket notification filed by Numed Technologies, Inc. with the FDA for Operating Scissors For Laparoscopic Surgeries.
Device ID | K923055 |
510k Number | K923055 |
Device Name: | OPERATING SCISSORS FOR LAPAROSCOPIC SURGERIES |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | NUMED TECHNOLOGIES, INC. 5755 GRANGER RD. Independence, OH 44131 |
Contact | Jan J Lewandowski |
Correspondent | Jan J Lewandowski NUMED TECHNOLOGIES, INC. 5755 GRANGER RD. Independence, OH 44131 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-24 |
Decision Date | 1992-11-23 |