510(k) K800250
K800250 is an FDA 510(k) premarket notification submitted by Associated Mills, Inc. for the device "HMB-200". The FDA issued a decision of Substantially Equivalent on March 25, 1980. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Associated Mills, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 1980
- Date Received
- February 6, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vibrator, Therapeutic
- Device Class
- Class I
- Regulation Number
- 890.5975
- Review Panel
- PM
- Submission Type