The following data is part of a premarket notification filed by On Site Gas Systems, Inc. with the FDA for Quickclot.
| Device ID | K013390 |
| 510k Number | K013390 |
| Device Name: | QUICKCLOT |
| Classification | Dressing, Wound, Drug |
| Applicant | ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. Newington, CT 06111 |
| Contact | C. Burton Gullong |
| Correspondent | C. Burton Gullong ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. Newington, CT 06111 |
| 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 | 2001-10-15 |
| Decision Date | 2002-05-23 |
| Summary: | summary |