510(k) K770956
K770956 is an FDA 510(k) premarket notification submitted by Hamilton Industries, Inc. for the device "PAS ANTI-EMBOLISM SYSTEM". The FDA issued a decision of Substantially Equivalent on September 12, 1977. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Hamilton Industries, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1977
- Date Received
- May 27, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type