510(k) K811793
K811793 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical Ind., Inc. for the device "FIX-RIGHT 90ML & 180 ML PREFILLED CONT". The FDA issued a decision of Substantially Equivalent on July 31, 1981. The device falls under product code KDT (Container, Specimen Mailer And Storage, Sterile), a Class I device regulated under 21 CFR 864.3250. Richard-Allan Medical Ind., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1981
- Date Received
- June 24, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Specimen Mailer And Storage, Sterile
- Device Class
- Class I
- Regulation Number
- 864.3250
- Review Panel
- PA
- Submission Type