The following data is part of a premarket notification filed by Wfr/aquaplast Corp. with the FDA for Kvue Igrt Treatment Table Top, Rt-4551kv, Kvue Inserts And Accessories, Various.
Device ID | K060671 |
510k Number | K060671 |
Device Name: | KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS |
Classification | Couch, Radiation Therapy, Powered |
Applicant | WFR/AQUAPLAST CORP. 30 LAWLINS PARK Wyckoff, NJ 07481 |
Contact | J. Damon Kirk |
Correspondent | J. Damon Kirk WFR/AQUAPLAST CORP. 30 LAWLINS PARK Wyckoff, NJ 07481 |
Product Code | JAI |
CFR Regulation Number | 892.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-14 |
Decision Date | 2006-05-04 |