The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Interstim 100 System.
| Device ID | K861136 |
| 510k Number | K861136 |
| Device Name: | INTERSTIM 100 SYSTEM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-26 |
| Decision Date | 1986-07-09 |