The following data is part of a premarket notification filed by American Seal Co. with the FDA for Non-sterile Isolation Gown.
| Device ID | K970814 |
| 510k Number | K970814 |
| Device Name: | NON-STERILE ISOLATION GOWN |
| Classification | Gown, Isolation, Surgical |
| Applicant | AMERICAN SEAL CO. 25029 VIKING ST. Hayward, CA 94545 |
| Contact | Joseph Tung |
| Correspondent | Joseph Tung AMERICAN SEAL CO. 25029 VIKING ST. Hayward, CA 94545 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-06 |
| Decision Date | 1997-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M752SS6010B1 | K970814 | 000 |