The following data is part of a premarket notification filed by Tenet Medical Engineering with the FDA for Tenet Mlti-positioning Surgical Stirrup System.
| Device ID | K963505 |
| 510k Number | K963505 |
| Device Name: | TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM |
| Classification | Table, Obstetrical, Manual (and Accessories) |
| Applicant | TENET MEDICAL ENGINEERING 3553 31ST ST., N.W. Calgary, CA T2l 2k7 |
| Contact | Ken Moore |
| Correspondent | Ken Moore TENET MEDICAL ENGINEERING 3553 31ST ST., N.W. Calgary, CA T2l 2k7 |
| Product Code | HHP |
| CFR Regulation Number | 884.4900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1997-02-14 |