The following data is part of a premarket notification filed by Clinitech, Inc. with the FDA for Sterile Back Gown/stand Back Gown(various Sizes).
| Device ID | K864311 |
| 510k Number | K864311 |
| Device Name: | STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES) |
| Classification | Gown, Surgical |
| Applicant | CLINITECH, INC. 1245 NORHT DEARBORN, #3S Chicago, IL 60610 |
| Contact | Dennis Crowley |
| Correspondent | Dennis Crowley CLINITECH, INC. 1245 NORHT DEARBORN, #3S Chicago, IL 60610 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-03 |
| Decision Date | 1986-11-26 |