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 |