The following data is part of a premarket notification filed by Simpson/basye, Inc. with the FDA for Heated Instrument Bath.
Device ID | K870276 |
510k Number | K870276 |
Device Name: | HEATED INSTRUMENT BATH |
Classification | Disinfectant, Medical Devices |
Applicant | SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington, DE 19804 |
Contact | Robert A Basye |
Correspondent | Robert A Basye SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington, DE 19804 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-27 |
Decision Date | 1987-05-07 |