The following data is part of a premarket notification filed by Vector, Inc. with the FDA for First Aid Kit(s).
Device ID | K963298 |
510k Number | K963298 |
Device Name: | FIRST AID KIT(S) |
Classification | Mask, Oxygen |
Applicant | VECTOR, INC. 6576 EAST QUAKER ST. Orchard Park, NY 14127 -2593 |
Contact | Jon Heavey |
Correspondent | Jon Heavey VECTOR, INC. 6576 EAST QUAKER ST. Orchard Park, NY 14127 -2593 |
Product Code | BYG |
CFR Regulation Number | 868.5580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-21 |
Decision Date | 1996-11-06 |