510(k) K943177
K943177 is an FDA 510(k) premarket notification submitted by Polymer Technology Corp. for the device "BOSTON(R) 7 - 30(ENFLUFOCON A)". The FDA issued a decision of Substantially Equivalent on August 25, 1994. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Polymer Technology Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 1994
- Date Received
- July 1, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact (Other Material) - Daily
- Device Class
- Class II
- Regulation Number
- 886.5916
- Review Panel
- OP
- Submission Type