510(k) K853600
K853600 is an FDA 510(k) premarket notification submitted by Hospitak, Inc. for the device "INFLATABLE AIR SPLINTS". The FDA issued a decision of Substantially Equivalent on September 19, 1985. The device falls under product code FZF (Splint, Extremity, Inflatable, External), a Class I device regulated under 21 CFR 878.3900. Hospitak, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 1985
- Date Received
- August 27, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Extremity, Inflatable, External
- Device Class
- Class I
- Regulation Number
- 878.3900
- Review Panel
- SU
- Submission Type