The following data is part of a premarket notification filed by Columbus Mckinnon Corp. with the FDA for Personal Transfer System.
Device ID | K885270 |
510k Number | K885270 |
Device Name: | PERSONAL TRANSFER SYSTEM |
Classification | Lift, Patient, Ac-powered |
Applicant | COLUMBUS MCKINNON CORP. TONAWANDA OPERATIONS ONE FREMONT STREET Tonawanda, NY 14151 |
Contact | Earl L Loeswick |
Correspondent | Earl L Loeswick COLUMBUS MCKINNON CORP. TONAWANDA OPERATIONS ONE FREMONT STREET Tonawanda, NY 14151 |
Product Code | FNG |
CFR Regulation Number | 880.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-22 |
Decision Date | 1989-03-14 |