510(k) K862851
K862851 is an FDA 510(k) premarket notification submitted by Almore Intl., Inc. for the device "ALMORE FACE MASK". The FDA issued a decision of Substantially Equivalent on August 12, 1986. Almore Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1986
- Date Received
- July 29, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No