510(k) K820375
K820375 is an FDA 510(k) premarket notification submitted by Gazelle Corp. for the device "PLASTIC OR GLASS MAGNIFIER". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code HJF (Magnifier, Hand-Held, Low-Vision), a Class I device regulated under 21 CFR 886.5540. Gazelle Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 1982
- Date Received
- February 9, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Magnifier, Hand-Held, Low-Vision
- Device Class
- Class I
- Regulation Number
- 886.5540
- Review Panel
- OP
- Submission Type