The following data is part of a premarket notification filed by Spencer Fillmore with the FDA for Kobold Sure-guide Vaginal Cylinder Set, Stump Vaginal Cylinder Set, Miami Cylinder Set.
| Device ID | K123941 |
| 510k Number | K123941 |
| Device Name: | KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | SPENCER FILLMORE 2670 LEAVENWORTH ST. San Francisco, CA 94133 |
| Contact | Christina Bernstein |
| Correspondent | Christina Bernstein SPENCER FILLMORE 2670 LEAVENWORTH ST. San Francisco, CA 94133 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-20 |
| Decision Date | 2013-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815568020236 | K123941 | 000 |
| 00815568020205 | K123941 | 000 |
| 00815568020076 | K123941 | 000 |
| 00815568020991 | K123941 | 000 |