The following data is part of a premarket notification filed by Alain Machtelinckx with the FDA for Hooking System.
Device ID | K930613 |
510k Number | K930613 |
Device Name: | HOOKING SYSTEM |
Classification | Massager, Therapeutic, Manual |
Applicant | ALAIN MACHTELINCKX 2148 CLUB HOUSE DR. West Linn, OR 97068 |
Contact | Alain Machtelinckx |
Correspondent | Alain Machtelinckx ALAIN MACHTELINCKX 2148 CLUB HOUSE DR. West Linn, OR 97068 |
Product Code | LYG |
CFR Regulation Number | 890.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-05 |
Decision Date | 1994-07-12 |