510(k) K875124
K875124 is an FDA 510(k) premarket notification submitted by Seiler Instrument & Mfg. Co., Inc. for the device "LOW-POWER BINOCULAR LOUPE". The FDA issued a decision of Substantially Equivalent on February 19, 1988. The device falls under product code HOH (Spectacle, Operating (Loupe), Ophthalmic), a Class I device regulated under 21 CFR 886.4770.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1988
- Date Received
- December 15, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spectacle, Operating (Loupe), Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4770
- Review Panel
- OP
- Submission Type