The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Knife Maker.
Device ID | K863616 |
510k Number | K863616 |
Device Name: | KNIFE MAKER |
Classification | Microtome, Accessories |
Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
Contact | Urban, Ht(ascp) |
Correspondent | Urban, Ht(ascp) SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
Product Code | IDL |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-16 |
Decision Date | 1986-09-25 |