The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Orthovision Table.
| Device ID | K905816 |
| 510k Number | K905816 |
| Device Name: | ORTHOVISION TABLE |
| Classification | Table, Surgical With Orthopedic Accessories, Manual |
| Applicant | AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Contact | Michael J Zmuda |
| Correspondent | Michael J Zmuda AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Product Code | JEB |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-28 |
| Decision Date | 1991-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995164669 | K905816 | 000 |