The following data is part of a premarket notification filed by Micromedics Inc. (d/b/a Nordson Medical) with the FDA for Laparoscopic Spray Applicator With Spinning Luers.
| Device ID | K162077 |
| 510k Number | K162077 |
| Device Name: | Laparoscopic Spray Applicator With Spinning Luers |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICROMEDICS INC. (D/B/A NORDSON MEDICAL) 1270 EAGAN INDUSTRIAL RD, SUITE 120 St. Paul, MN 55121 |
| Contact | Amy L. Peterson |
| Correspondent | Amy L. Peterson MICROMEDICS INC. (D/B/A NORDSON MEDICAL) 1270 EAGAN INDUSTRIAL RD, 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 | 2016-07-27 |
| Decision Date | 2016-08-11 |
| Summary: | summary |