510(k) K912197
K912197 is an FDA 510(k) premarket notification submitted by Alpine Specialties, Inc. for the device "SKIN SAVER(TM) TUBING HOLDER, MODEL 467". The FDA issued a decision of Substantially Equivalent on August 20, 1991. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340. Alpine Specialties, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 1991
- Date Received
- May 17, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Nasal, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5340
- Review Panel
- AN
- Submission Type