510(k) K802690
K802690 is an FDA 510(k) premarket notification submitted by Occumedics, Inc. for the device "ULTRAPAK CAT. #100-0251". The FDA issued a decision of Substantially Equivalent on January 8, 1981. The device falls under product code HYG (Glenner'S Stain), a Class I device regulated under 21 CFR 864.1850. Occumedics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 1981
- Date Received
- October 27, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glenner'S Stain
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type