The following data is part of a premarket notification filed by General Medical Co. with the FDA for Exam Gown.
| Device ID | K770476 |
| 510k Number | K770476 |
| Device Name: | EXAM GOWN |
| Classification | Gown, Examination |
| Applicant | GENERAL MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FME |
| CFR Regulation Number | 880.6265 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-03-11 |
| Decision Date | 1977-05-06 |