The following data is part of a premarket notification filed by Whitney Medical Solutions with the FDA for Whitney Medical Solutions Eshield.
| Device ID | K141438 |
| 510k Number | K141438 |
| Device Name: | WHITNEY MEDICAL SOLUTIONS ESHIELD |
| Classification | Drape, Surgical |
| Applicant | WHITNEY MEDICAL SOLUTIONS 6153C WEST MULFORD STREET Niles, IL 60714 |
| Contact | Saagar Patel |
| Correspondent | Saagar Patel REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-05-30 |
| Decision Date | 2014-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M266EC24001 | K141438 | 000 |
| M266EC23001 | K141438 | 000 |
| M266EC22001 | K141438 | 000 |
| M266EC21001 | K141438 | 000 |