The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Kool Gard Singles Gown.
| Device ID | K952114 |
| 510k Number | K952114 |
| Device Name: | KOOL GARD SINGLES GOWN |
| Classification | Gown, Isolation, Surgical |
| Applicant | AMERICAN THRESHOLD INDUSTRIES, INC. P.O. BOX 1209 240 SARDIS ROAD Enka, NC 28728 |
| Contact | Gregory B Scott |
| Correspondent | Gregory B Scott AMERICAN THRESHOLD INDUSTRIES, INC. P.O. BOX 1209 240 SARDIS ROAD Enka, NC 28728 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-05 |
| Decision Date | 1995-09-25 |