510(k) K832590
K832590 is an FDA 510(k) premarket notification submitted by Mem, Inc. for the device "MOUTH-TO-MOUTH SHIELD APPLICATOR". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code LAE (High Pressure Liquid Chromatography, Codeine), a Class II device regulated under 21 CFR 862.3270. Mem, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 1983
- Date Received
- August 2, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- High Pressure Liquid Chromatography, Codeine
- Device Class
- Class II
- Regulation Number
- 862.3270
- Review Panel
- TX
- Submission Type