The following data is part of a premarket notification filed by Envirotents, Inc. with the FDA for Envirotent (bed).
Device ID | K881725 |
510k Number | K881725 |
Device Name: | ENVIROTENT (BED) |
Classification | Bed, Manual |
Applicant | ENVIROTENTS, INC. 1550 SOUTH PEARL ST., #210-D Denver, CO 80210 |
Contact | C Powers |
Correspondent | C Powers ENVIROTENTS, INC. 1550 SOUTH PEARL ST., #210-D Denver, CO 80210 |
Product Code | FNJ |
CFR Regulation Number | 880.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-22 |
Decision Date | 1988-11-08 |