The following data is part of a premarket notification filed by Nbs Products Co with the FDA for Nbs Connecting Tube Set.
Device ID | K001068 |
510k Number | K001068 |
Device Name: | NBS CONNECTING TUBE SET |
Classification | Insufflator, Laparoscopic |
Applicant | NBS PRODUCTS CO 257 LIVINGSTON AVE. New Brunswick, NJ 08901 |
Contact | Charles E Meisch |
Correspondent | Charles E Meisch NBS PRODUCTS CO 257 LIVINGSTON AVE. New Brunswick, NJ 08901 |
Product Code | HIF |
Subsequent Product Code | GCJ |
Subsequent Product Code | JCX |
Subsequent Product Code | KNX |
CFR Regulation Number | 884.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-03 |
Decision Date | 2000-06-14 |