510(k) K821857
K821857 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "BK-5305 MULTIPLE HAND GRID". The FDA issued a decision of Substantially Equivalent on July 2, 1982. The device falls under product code ION (Exerciser, Non-Measuring), a Class I device regulated under 21 CFR 890.5370. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 1982
- Date Received
- June 23, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Non-Measuring
- Device Class
- Class I
- Regulation Number
- 890.5370
- Review Panel
- PM
- Submission Type