The following data is part of a premarket notification filed by Ridge Products, Inc. with the FDA for Rpi Dual Port Irrigation Adapter.
Device ID | K964920 |
510k Number | K964920 |
Device Name: | RPI DUAL PORT IRRIGATION ADAPTER |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | RIDGE PRODUCTS, INC. 170 OBERLIN AVE. NORTH Lakewood, NJ 08701 |
Contact | Richard G Voelker |
Correspondent | Richard G Voelker RIDGE PRODUCTS, INC. 170 OBERLIN AVE. NORTH Lakewood, NJ 08701 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-09 |
Decision Date | 1997-07-09 |