510(k) K821693
K821693 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "J & J DIP WATER ADDITIVE". The FDA issued a decision of Substantially Equivalent on July 2, 1982. The device falls under product code FYH (Splint, Extremity, Noninflatable, External, Sterile), a Class I device regulated under 21 CFR 878.3910. Johnson & Johnson Professionals, 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 8, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Extremity, Noninflatable, External, Sterile
- Device Class
- Class I
- Regulation Number
- 878.3910
- Review Panel
- HO
- Submission Type