STERI-PAK BOWIE DICK TEST PACK— 510(k) K982188
Substantially EquivalentSteritec Products Mfg Co, Inc.
FDA 510(k) clearance K982188 for STERI-PAK BOWIE DICK TEST PACK, Substantially Equivalent on 1998-11-20. Applicant: Steritec Products Mfg Co, Inc.. Device class: 2.
Clearance details
- Applicant
- Steritec Products Mfg Co, Inc.
- Product code
- Code JOJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castle Rock, CO, US
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Recalls naming K982188
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982188.
Data sourced from openFDA. This site is unofficial and independent of the FDA.