The following data is part of a premarket notification filed by Hans Rudolph, Inc. with the FDA for Ultimate Seal.
| Device ID | K960401 |
| 510k Number | K960401 |
| Device Name: | ULTIMATE SEAL |
| Classification | Mask, Oxygen, Non-rebreathing |
| Applicant | HANS RUDOLPH, INC. 7200 WYANDOTTE Kansas City, MO 64114 |
| Contact | Kevin Rudolph |
| Correspondent | Kevin Rudolph HANS RUDOLPH, INC. 7200 WYANDOTTE Kansas City, MO 64114 |
| Product Code | KGB |
| CFR Regulation Number | 868.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-29 |
| Decision Date | 1996-06-20 |