The following data is part of a premarket notification filed by Nusurg, Inc. with the FDA for Laparoscopic Nerve Hook.
Device ID | K924372 |
510k Number | K924372 |
Device Name: | LAPAROSCOPIC NERVE HOOK |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | NUSURG, INC. 7432 JAGER COURT Cincinnati, OH 45230 |
Contact | Dennis R Lackey |
Correspondent | Dennis R Lackey NUSURG, INC. 7432 JAGER COURT Cincinnati, OH 45230 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-28 |
Decision Date | 1993-07-30 |