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 |