The following data is part of a premarket notification filed by Orthophor, Llc with the FDA for Surgiphor Wound Irrigation System.
| Device ID | K202071 |
| 510k Number | K202071 |
| Device Name: | SURGIPHOR Wound Irrigation System |
| Classification | Lavage, Jet |
| Applicant | Orthophor, LLC 125 S. 9th Street Sheridan Building, Suite 1001 Philadelphia, PA 19107 |
| Contact | Alan Miller |
| Correspondent | Elizabeth O’keeffe Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2020-07-27 |
| Decision Date | 2020-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382909101008 | K202071 | 000 |