The following data is part of a premarket notification filed by J.r. Parker, Llc with the FDA for Jrp Wound Spreader.
| Device ID | K152538 |
| 510k Number | K152538 |
| Device Name: | JRP Wound Spreader |
| Classification | Retractor |
| Applicant | J.R. PARKER, LLC 1665 WARPATH ROAD West Chester, PA 19382 |
| Contact | J Richard Parker |
| Correspondent | J. Richard Parker J.R. PARKER, LLC 1665 Warpath Road West Chester, PA 19382 -1745 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-04 |
| Decision Date | 2016-04-13 |
| Summary: | summary |