510(k) K873820
K873820 is an FDA 510(k) premarket notification submitted by Applied Laboratories, Inc. for the device "MOBAY (BAYER) MAKROLON 2658 1112". The FDA issued a decision of Substantially Equivalent on March 24, 1988. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Applied Laboratories, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1988
- Date Received
- September 21, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Case, Contact Lens
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type