The following data is part of a premarket notification filed by Keystone Veterinary Supplies, Inc. with the FDA for Keystone Oxygen Tent.
Device ID | K893714 |
510k Number | K893714 |
Device Name: | KEYSTONE OXYGEN TENT |
Classification | Tent, Oxygen |
Applicant | KEYSTONE VETERINARY SUPPLIES, INC. 409 COMMERCE CENTER Blackwood, NJ 08012 |
Contact | Robert Delano |
Correspondent | Robert Delano KEYSTONE VETERINARY SUPPLIES, INC. 409 COMMERCE CENTER Blackwood, NJ 08012 |
Product Code | BYL |
CFR Regulation Number | 868.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-18 |
Decision Date | 1989-08-21 |