510(k) K891187
K891187 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL NASO-GASTRIC TUBE HOLDER". The FDA issued a decision of Substantially Equivalent on May 30, 1989. The device falls under product code BSS (Tube, Nasogastric), a Class II device regulated under 21 CFR 876.5980. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 1989
- Date Received
- March 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Nasogastric
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type