The following data is part of a premarket notification filed by Jayco Pharmaceuticals with the FDA for Endo-guard.
Device ID | K830781 |
510k Number | K830781 |
Device Name: | ENDO-GUARD |
Classification | Hood, Oxygen, Infant |
Applicant | JAYCO PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FOG |
CFR Regulation Number | 868.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-11 |
Decision Date | 1983-03-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00350770928098 | K830781 | 000 |
00350770928081 | K830781 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDO-GUARD 74167201 1690024 Live/Registered |
AVENT, INC. 1991-05-16 |