The following data is part of a premarket notification filed by Site Microsurgical Systems, Inc. with the FDA for Modified Site Mobile Stand For Ophthalmic Use.
Device ID | K883575 |
510k Number | K883575 |
Device Name: | MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE |
Classification | Stand, Instrument, Ophthalmic, Non-powered |
Applicant | SITE MICROSURGICAL SYSTEMS, INC. 135 GIBRALTAR RD. Horsham, PA 19044 |
Contact | James K Mccracken |
Correspondent | James K Mccracken SITE MICROSURGICAL SYSTEMS, INC. 135 GIBRALTAR RD. Horsham, PA 19044 |
Product Code | HMG |
CFR Regulation Number | 886.1860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-22 |
Decision Date | 1988-09-12 |