510(k) K884514
K884514 is an FDA 510(k) premarket notification submitted by Gatewood and Associates, Ltd. for the device "FORCEPS, TOWEL, BACKHAUS-TSK (BRAND) TOWEL". The FDA issued a decision of Substantially Equivalent on November 17, 1988. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Gatewood and Associates, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 1988
- Date Received
- October 27, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type