The following data is part of a premarket notification filed by Instrumentation Specialties, Inc. with the FDA for K Orthopedic Table.
| Device ID | K881101 |
| 510k Number | K881101 |
| Device Name: | K ORTHOPEDIC TABLE |
| Classification | Table, Surgical With Orthopedic Accessories, Manual |
| Applicant | INSTRUMENTATION SPECIALTIES, INC. 15700 CHASE HILL BLVD. San Antonio, TX 78256 |
| Contact | Joseph R Kabanek |
| Correspondent | Joseph R Kabanek INSTRUMENTATION SPECIALTIES, INC. 15700 CHASE HILL BLVD. San Antonio, TX 78256 |
| Product Code | JEB |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-15 |
| Decision Date | 1988-04-06 |