510(k) K790186
K790186 is an FDA 510(k) premarket notification submitted by Jelco Laboratories for the device "PROTECTIVSTABILIZER". The FDA issued a decision of Substantially Equivalent on February 26, 1979. The device falls under product code GBJ (Prosthesis, Adhesive, External), a Class I device regulated under 21 CFR 878.3750. Jelco Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1979
- Date Received
- January 29, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Adhesive, External
- Device Class
- Class I
- Regulation Number
- 878.3750
- Review Panel
- SU
- Submission Type