The following data is part of a premarket notification filed by Narco Scientific with the FDA for Pilling Diamond Knife.
Device ID | K822749 |
510k Number | K822749 |
Device Name: | PILLING DIAMOND KNIFE |
Classification | Scalpel, One-piece |
Applicant | NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GDX |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-10 |
Decision Date | 1982-10-06 |