The following data is part of a premarket notification filed by Seoil Pacific Corp. with the FDA for Comfort Cough.
| Device ID | K113549 |
| 510k Number | K113549 |
| Device Name: | COMFORT COUGH |
| Classification | Device, Positive Pressure Breathing, Intermittent |
| Applicant | SEOIL PACIFIC CORP. RM # 515-516, ACE HIGH-END TOWER 235-2 GURO-DONG Seoul, KR 573-901 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung SEOIL PACIFIC CORP. RM # 515-516, ACE HIGH-END TOWER 235-2 GURO-DONG Seoul, KR 573-901 |
| Product Code | NHJ |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-01 |
| Decision Date | 2013-02-21 |
| Summary: | summary |