The following data is part of a premarket notification filed by Medical Resources with the FDA for Sheathes (non-latex).
| Device ID | K963831 |
| 510k Number | K963831 |
| Device Name: | SHEATHES (NON-LATEX) |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | MEDICAL RESOURCES 334 COMMERICAL ST. San Jose, CA 95112 |
| Contact | Lawrence S Polayes |
| Correspondent | Lawrence S Polayes MEDICAL RESOURCES 334 COMMERICAL ST. San Jose, CA 95112 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-24 |
| Decision Date | 1997-02-10 |