510(k) K111856
K111856 is an FDA 510(k) premarket notification submitted by Apothecary Products, Inc. for the device "SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE". The FDA issued a decision of Substantially Equivalent on July 14, 2011. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Apothecary Products, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2011
- Date Received
- June 29, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Case, Contact Lens
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type