The following data is part of a premarket notification filed by Intera Corp. with the FDA for Surgical Gown/scrub/laparotomy/mayo Stand/back Tab.
| Device ID | K883424 |
| 510k Number | K883424 |
| Device Name: | SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB |
| Classification | Drape, Surgical |
| Applicant | INTERA CORP. P.O. BOX 25376 Chattanooga, TN 37422 -5376 |
| Contact | Larry English |
| Correspondent | Larry English INTERA CORP. P.O. BOX 25376 Chattanooga, TN 37422 -5376 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1988-09-06 |