The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Source Guide Tube With Locking Mechanism For 113 Mm Needles, Gammamedplus.
| Device ID | K141336 |
| 510k Number | K141336 |
| Device Name: | SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | VARIAN MEDICAL SYSTEMS, INC. 911 HANSEN WAY Palo Alto, CA 94304 |
| Contact | Peter J Coronado |
| Correspondent | Peter J Coronado VARIAN MEDICAL SYSTEMS, INC. 911 HANSEN WAY Palo Alto, CA 94304 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-21 |
| Decision Date | 2014-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389025165 | K141336 | 000 |
| 00816389024007 | K141336 | 000 |
| 00816389023994 | K141336 | 000 |
| 00816389023987 | K141336 | 000 |
| 00816389023970 | K141336 | 000 |
| 00816389023963 | K141336 | 000 |
| 00816389023796 | K141336 | 000 |
| 00816389023642 | K141336 | 000 |
| 00816389021570 | K141336 | 000 |
| 00816389021556 | K141336 | 000 |
| 00816389021525 | K141336 | 000 |
| 00816389021518 | K141336 | 000 |
| 00816389021495 | K141336 | 000 |
| 00816389021471 | K141336 | 000 |
| 00816389021464 | K141336 | 000 |
| 10816389027166 | K141336 | 000 |
| 10816389027135 | K141336 | 000 |
| 00816389029422 | K141336 | 000 |
| 00816389024014 | K141336 | 000 |
| 00816389024021 | K141336 | 000 |
| 00816389024038 | K141336 | 000 |
| 00816389024762 | K141336 | 000 |
| 00816389024755 | K141336 | 000 |
| 00816389024687 | K141336 | 000 |
| 00816389024670 | K141336 | 000 |
| 00816389024663 | K141336 | 000 |
| 00816389024618 | K141336 | 000 |
| 00816389024601 | K141336 | 000 |
| 00816389024595 | K141336 | 000 |
| 00816389024274 | K141336 | 000 |
| 00816389024236 | K141336 | 000 |
| 00816389024113 | K141336 | 000 |
| 00816389024090 | K141336 | 000 |
| 00816389024083 | K141336 | 000 |
| 00816389024076 | K141336 | 000 |
| 00816389024069 | K141336 | 000 |
| 00816389024052 | K141336 | 000 |
| 00816389024045 | K141336 | 000 |
| 00816389029415 | K141336 | 000 |