The following data is part of a premarket notification filed by Rifton Equipment For The Handicapped with the FDA for E65 35 Prone Stander.
Device ID | K892700 |
510k Number | K892700 |
Device Name: | E65 35 PRONE STANDER |
Classification | Table, Mechanical |
Applicant | RIFTON EQUIPMENT FOR THE HANDICAPPED ROUTE 213 Rifton, NY 12471 |
Contact | John Rhodes |
Correspondent | John Rhodes RIFTON EQUIPMENT FOR THE HANDICAPPED ROUTE 213 Rifton, NY 12471 |
Product Code | INW |
CFR Regulation Number | 890.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-13 |
Decision Date | 1989-05-09 |