ZARA SILICONE BLOCK— 510(k) K913882
Substantially EquivalentByron Medical
FDA 510(k) clearance K913882 for ZARA SILICONE BLOCK, Substantially Equivalent on 1992-04-21. Applicant: Byron Medical. Device class: 2.
Clearance details
- Applicant
- Byron Medical
- Product code
- Code MIB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
Recent devices under product code MIB
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view all- K040149 — PSI-TEC PERISTALTIC INFILTRATION PUMP
- K001803 — ACCELERATOR RECIPROCATING CANNULA
- K981215 — PSI-TEC LIPOSUCTION ASPIRATOR
- K981172 — LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES
- K980738 — PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION
Adverse events under product code MIB
product code MIB- Injury
- 146
- Total
- 146
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.