The following data is part of a premarket notification filed by North American Philips Corp. with the FDA for Norelco Vibrating Board V900.
Device ID | K830715 |
510k Number | K830715 |
Device Name: | NORELCO VIBRATING BOARD V900 |
Classification | Vibrator, Therapeutic |
Applicant | NORTH AMERICAN PHILIPS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IRO |
CFR Regulation Number | 890.5975 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-09 |
Decision Date | 1983-05-25 |