510(k) K930697
K930697 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "MEDLINE STERILE GAUZE SPONGES". The FDA issued a decision of Substantially Equivalent on June 24, 1993. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1993
- Date Received
- February 10, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Occlusive
- Device Class
- Class I
- Regulation Number
- 878.4020
- Review Panel
- SU
- Submission Type