The following data is part of a premarket notification filed by Network Medical Products, Ltd. with the FDA for Network Eye Spears, Points, Drains, Wicks And Shields.
Device ID | K130117 |
510k Number | K130117 |
Device Name: | NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS |
Classification | Sponge, Ophthalmic |
Applicant | NETWORK MEDICAL PRODUCTS, LTD. Coronet House, Kearsley Road Ripon, GB Hg4 2sg |
Contact | Alison March |
Correspondent | Alison March NETWORK MEDICAL PRODUCTS, LTD. Coronet House, Kearsley Road Ripon, GB Hg4 2sg |
Product Code | HOZ |
CFR Regulation Number | 886.4790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-16 |
Decision Date | 2013-10-29 |
Summary: | summary |