The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Lancer Biopsy Holder.
Device ID | K772149 |
510k Number | K772149 |
Device Name: | LANCER BIOPSY HOLDER |
Classification | Container, Embedding |
Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KER |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-11-14 |
Decision Date | 1977-11-22 |