510(k) K913643
K913643 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "MUCOUS SPECIMEN TRAP". The FDA issued a decision of Substantially Equivalent on October 10, 1991. The device falls under product code BYZ (Trap, Sterile Specimen), a Class II device regulated under 21 CFR 880.6740. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1991
- Date Received
- August 14, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trap, Sterile Specimen
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type