The following data is part of a premarket notification filed by Microbio-medics, Inc. with the FDA for Microtek-heritages Silicone Bulb Evacuation System.
| Device ID | K910167 |
| 510k Number | K910167 |
| Device Name: | MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | MICROBIO-MEDICS, INC. P.O. BOX 1147 Tucker, GA 30085 |
| Contact | Gregory A Smallwood |
| Correspondent | Gregory A Smallwood MICROBIO-MEDICS, INC. P.O. BOX 1147 Tucker, GA 30085 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-15 |
| Decision Date | 1991-04-15 |