The following data is part of a premarket notification filed by Surgi-med, Inc. with the FDA for Paragon 9000 Tilt And Turn Bed.
Device ID | K872923 |
510k Number | K872923 |
Device Name: | PARAGON 9000 TILT AND TURN BED |
Classification | Bed, Ac-powered Adjustable Hospital |
Applicant | SURGI-MED, INC. 815 TERMINAL RD. Lansing, MI 48906 |
Contact | Donald J Propp |
Correspondent | Donald J Propp SURGI-MED, INC. 815 TERMINAL RD. Lansing, MI 48906 |
Product Code | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-27 |
Decision Date | 1987-10-14 |