510(k) K880253
K880253 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "BLAKEMORE RETAINER". The FDA issued a decision of Substantially Equivalent on March 11, 1988. The device falls under product code FEF (Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression), a Class II device regulated under 21 CFR 876.5980. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1988
- Date Received
- January 20, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type