The following data is part of a premarket notification filed by Spencer Fillmore with the FDA for Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator Set.
| Device ID | K123912 |
| 510k Number | K123912 |
| Device Name: | KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR 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 | 2012-12-19 |
| Decision Date | 2013-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815568020199 | K123912 | 000 |
| 00815568020182 | K123912 | 000 |
| 00815568020021 | K123912 | 000 |
| 00815568020014 | K123912 | 000 |
| 00815568020007 | K123912 | 000 |
| 00815568020984 | K123912 | 000 |
| 00815568020977 | K123912 | 000 |
| 00815568020922 | K123912 | 000 |