510(k) K833872
K833872 is an FDA 510(k) premarket notification submitted by Sil-Med Corp. for the device "SAV-A-LIMB". The FDA issued a decision of Substantially Equivalent on Feb 4, 1984. The device falls under product code KYR (Bag, Ice), a Class I device regulated under 21 CFR 880.6050. Sil-Med Corp. has 28 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 4, 1984
- Date Received
- Nov 8, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Bag, Ice
- Device Class
- Class I
- Regulation Number
- 880.6050
- Review Panel
- HO
- Submission Type
- 510(k) Exempt