510(k) K925841
K925841 is an FDA 510(k) premarket notification submitted by Avitar, Inc. for the device "HYDRASORB JOYCE SPONGE". The FDA issued a decision of Substantially Equivalent on May 12, 1993. The device falls under product code NAC (Dressing, Wound, Hydrophilic), a Class I device regulated under 21 CFR 878.4018. Avitar, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 1993
- Date Received
- November 18, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Hydrophilic
- Device Class
- Class I
- Regulation Number
- 878.4018
- Review Panel
- SU
- Submission Type