The following data is part of a premarket notification filed by Instrumentation Specialties, Inc. with the FDA for Isi Self-supporting Arm.
| Device ID | K925005 |
| 510k Number | K925005 |
| Device Name: | ISI SELF-SUPPORTING ARM |
| Classification | Table And Attachments, Operating-room |
| Applicant | INSTRUMENTATION SPECIALTIES, INC. 32390 IH-10 WEST Boerne, TX 78006 |
| Contact | Joseph R Kabanek |
| Correspondent | Joseph R Kabanek INSTRUMENTATION SPECIALTIES, INC. 32390 IH-10 WEST Boerne, TX 78006 |
| Product Code | BWN |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-02 |
| Decision Date | 1993-04-29 |