The following data is part of a premarket notification filed by Hedges Cwp, Inc. with the FDA for Hedges Corneal Wetting Pak.
| Device ID | K970161 |
| 510k Number | K970161 |
| Device Name: | HEDGES CORNEAL WETTING PAK |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | HEDGES CWP, INC. 105 SPRING HOUSE COURT Cherry Hill, NJ 08002 |
| Contact | David Jaspan |
| Correspondent | David Jaspan HEDGES CWP, INC. 105 SPRING HOUSE COURT Cherry Hill, NJ 08002 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-14 |
| Decision Date | 1997-03-25 |