The following data is part of a premarket notification filed by Anup Chakraborty Co. with the FDA for Stethoscope Cover.
| Device ID | K923327 |
| 510k Number | K923327 |
| Device Name: | STETHOSCOPE COVER |
| Classification | Stethoscope, Manual |
| Applicant | ANUP CHAKRABORTY CO. 6510 PONDEROSA CIRCLE Lincoln, NE 68510 |
| Contact | Anup Chakraborty |
| Correspondent | Anup Chakraborty ANUP CHAKRABORTY CO. 6510 PONDEROSA CIRCLE Lincoln, NE 68510 |
| Product Code | LDE |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-07 |
| Decision Date | 1992-11-03 |