The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Malleable Suction Instruments.
| Device ID | K133665 |
| 510k Number | K133665 |
| Device Name: | MALLEABLE SUCTION INSTRUMENTS |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIR. Louisville, CO 80027 |
| Contact | Charles M Copperberg |
| Correspondent | Charles M Copperberg MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIR. Louisville, CO 80027 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-29 |
| Decision Date | 2014-03-13 |
| Summary: | summary |