HYALURONIDASE, 80 U/ML— 510(k) K991393
Substantially EquivalentSage Biopharma
FDA 510(k) clearance K991393 for HYALURONIDASE, 80 U/ML, Substantially Equivalent on 2000-02-02. Applicant: Sage Biopharma. Device class: 2.
Clearance details
- Applicant
- Sage Biopharma
- Product code
- Code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.