The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Sheathes, Sterile Sheathes.
| Device ID | K925869 |
| 510k Number | K925869 |
| Device Name: | SHEATHES, STERILE SHEATHES |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | MAYER LABORATORIES 231 FALLON ST. Oakland, CA 94607 |
| Contact | David P Mayer |
| Correspondent | David P Mayer MAYER LABORATORIES 231 FALLON ST. Oakland, CA 94607 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-19 |
| Decision Date | 1994-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20842418100118 | K925869 | 000 |
| 20842418100200 | K925869 | 000 |
| 20842418100156 | K925869 | 000 |
| 20842418100125 | K925869 | 000 |
| 20842418100002 | K925869 | 000 |