The following data is part of a premarket notification filed by Lumex, Inc. with the FDA for Shower Chairs;bed/stretcher;linen & Utility Cart.
Device ID | K895740 |
510k Number | K895740 |
Device Name: | SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART |
Classification | Stretcher, Wheeled |
Applicant | LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
Contact | Warren Wartell |
Correspondent | Warren Wartell LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
Product Code | FPO |
CFR Regulation Number | 880.6910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-26 |
Decision Date | 1990-02-22 |