The following data is part of a premarket notification filed by Walter Abendschein, M.d. with the FDA for Vhs Pediatric Hip Screw System.
Device ID | K011603 |
510k Number | K011603 |
Device Name: | VHS PEDIATRIC HIP SCREW SYSTEM |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | WALTER ABENDSCHEIN, M.D. 5530 WISCONSIN AVE. SUITE 705 Chevy Chase, MD 20815 |
Contact | Walter Abendschein |
Correspondent | Walter Abendschein WALTER ABENDSCHEIN, M.D. 5530 WISCONSIN AVE. SUITE 705 Chevy Chase, MD 20815 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-24 |
Decision Date | 2001-08-15 |
Summary: | summary |