510(k) K910687
K910687 is an FDA 510(k) premarket notification submitted by Guardian Angel Products, Inc. for the device "GUARDIAN GEL, SURGEON'S GLOVING CREAM". The FDA issued a decision of Substantially Equivalent on October 11, 1991. The device falls under product code KGQ (Cream, Gloving, Surgeon'S), a Class I device regulated under 21 CFR 878.4470. Guardian Angel Products, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 1991
- Date Received
- February 19, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cream, Gloving, Surgeon'S
- Device Class
- Class I
- Regulation Number
- 878.4470
- Review Panel
- HO
- Submission Type