The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Embedding Rings.
Device ID | K831333 |
510k Number | K831333 |
Device Name: | EMBEDDING RINGS |
Classification | Container, Embedding |
Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. MD |
Product Code | KER |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-25 |
Decision Date | 1983-05-25 |