The following data is part of a premarket notification filed by Innotherapy Inc. with the FDA for Innoseal Hemostatic Pad.
| Device ID | K161013 |
| 510k Number | K161013 |
| Device Name: | InnoSEAL Hemostatic Pad |
| Classification | Dressing, Wound, Drug |
| Applicant | InnoTherapy Inc. Ace Hightechcity2,25, Seonyu-ro 13-gil Yeongdeungpo-gu Seoul, KR 07282 |
| Contact | Moon Sue Lee |
| Correspondent | Robert Schiff Schiff & Company, Inc. 1120 Bloomfield Ave. West Caldwell, NJ 07282 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-11 |
| Decision Date | 2016-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800030700152 | K161013 | 000 |
| 08800030700121 | K161013 | 000 |