LATEX, IN-HOUSE COMPOUNDED— 510(k) K781847
Substantially EquivalentArbrook Mfg. Corp.
FDA 510(k) clearance K781847 for LATEX, IN-HOUSE COMPOUNDED, Substantially Equivalent on 1978-11-03. Applicant: Arbrook Mfg. Corp.. Device class: 1.
Clearance details
- Applicant
- Arbrook Mfg. Corp.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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