The following data is part of a premarket notification filed by Bartels, Inc. with the FDA for H292.
| Device ID | K942820 |
| 510k Number | K942820 |
| Device Name: | H292 |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | BARTELS, INC. 2005 N.W. SAMMAMISH RD., #107 Issaquah, WA 98027 |
| Contact | Rebecca D Fuller |
| Correspondent | Rebecca D Fuller BARTELS, INC. 2005 N.W. SAMMAMISH RD., #107 Issaquah, WA 98027 |
| Product Code | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-15 |
| Decision Date | 1995-05-05 |