The following data is part of a premarket notification filed by D.t. Davis Enterprises Ltd. T/a Hovertech Int'l with the FDA for Hovertrans Transformer With Power Drive Model Htt-650p.
Device ID | K102236 |
510k Number | K102236 |
Device Name: | HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P |
Classification | Stretcher, Wheeled, Powered |
Applicant | D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L 513 SOUTH CLEWELL STREET Bethlehem, PA 18015 |
Contact | Susan Pavelko |
Correspondent | Susan Pavelko D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L 513 SOUTH CLEWELL STREET Bethlehem, PA 18015 |
Product Code | INK |
CFR Regulation Number | 890.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-09 |
Decision Date | 2010-11-18 |
Summary: | summary |