The following data is part of a premarket notification filed by Cher Mel Corp. with the FDA for Sprague Rappaport/sh-6008 Dispos. Steth.
| Device ID | K843324 |
| 510k Number | K843324 |
| Device Name: | SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH |
| Classification | Stethoscope, Manual |
| Applicant | CHER MEL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDE |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-24 |
| Decision Date | 1985-06-06 |