The following data is part of a premarket notification filed by Microbio-medics, Inc. with the FDA for Microtek Medical's Sound Stiks.
| Device ID | K913276 |
| 510k Number | K913276 |
| Device Name: | MICROTEK MEDICAL'S SOUND STIKS |
| Classification | Audiometer |
| Applicant | MICROBIO-MEDICS, INC. 1710 SHELBY OAKS DR. SUITE #21 Memphis, TN 38134 |
| Contact | Robert Quintanilla |
| Correspondent | Robert Quintanilla MICROBIO-MEDICS, INC. 1710 SHELBY OAKS DR. SUITE #21 Memphis, TN 38134 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-23 |
| Decision Date | 1991-10-21 |