The following data is part of a premarket notification filed by Biological Controls, Inc. with the FDA for Microcon 800muv, Microcon 400muv, Microcon Exc-buv.
| Device ID | K972064 |
| 510k Number | K972064 |
| Device Name: | MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | BIOLOGICAL CONTROLS, INC. ONE INDUSTRIAL WAY WEST BUILDING E, UNIT M Eatontown, NJ 07724 |
| Contact | Gary D Messina |
| Correspondent | Gary D Messina BIOLOGICAL CONTROLS, INC. ONE INDUSTRIAL WAY WEST BUILDING E, UNIT M Eatontown, NJ 07724 |
| Product Code | FRA |
| CFR Regulation Number | 880.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-03 |
| Decision Date | 1997-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811095020145 | K972064 | 000 |
| 00811095020121 | K972064 | 000 |
| 00811095020114 | K972064 | 000 |
| 00811095020107 | K972064 | 000 |
| 00811095020091 | K972064 | 000 |
| 00811095020060 | K972064 | 000 |
| 00811095020053 | K972064 | 000 |
| 00811095020046 | K972064 | 000 |
| 00811095020039 | K972064 | 000 |