The following data is part of a premarket notification filed by Ophthalmic Consultants, Inc. with the FDA for Scleral Plugs, 19 And 20 Gauge.
Device ID | K990872 |
510k Number | K990872 |
Device Name: | SCLERAL PLUGS, 19 AND 20 GAUGE |
Classification | Plug, Scleral |
Applicant | OPHTHALMIC CONSULTANTS, INC. 65 N. MAIN, SUITE 101 PO BOX 154 Tooele, UT 84074 |
Contact | John E Lincoln |
Correspondent | John E Lincoln OPHTHALMIC CONSULTANTS, INC. 65 N. MAIN, SUITE 101 PO BOX 154 Tooele, UT 84074 |
Product Code | LXP |
CFR Regulation Number | 886.4155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-16 |
Decision Date | 1999-07-13 |
Summary: | summary |