The following data is part of a premarket notification filed by Solos Ophthalmology with the FDA for Solos Eyesite Drapes.
Device ID | K872620 |
510k Number | K872620 |
Device Name: | SOLOS EYESITE DRAPES |
Classification | Drape, Patient, Ophthalmic |
Applicant | SOLOS OPHTHALMOLOGY 6191 ATLANTIC BLVD. Norcross, GA 30071 |
Contact | Stephen Holmes |
Correspondent | Stephen Holmes SOLOS OPHTHALMOLOGY 6191 ATLANTIC BLVD. Norcross, GA 30071 |
Product Code | HMT |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-06 |
Decision Date | 1987-07-31 |