The following data is part of a premarket notification filed by Micromedics Inc. (d/b/a Nordson Medical) with the FDA for Endoscopic Applicator, 41 Cm.
Device ID | K172672 |
510k Number | K172672 |
Device Name: | Endoscopic Applicator, 41 Cm |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | Micromedics Inc. (d/b/a Nordson Medical) 1270 Eagan Industrial Road, Suite 120 St.paul, MN 55121 |
Contact | Kristi Brezinka |
Correspondent | Kristi Brezinka Micromedics Inc. (d/b/a Nordson Medical) 1270 Eagan Industrial Road, Suite 120 St.paul, MN 55121 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-05 |
Decision Date | 2017-10-06 |