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 |