GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300— 510(k) K853291
Substantially EquivalentBio-Detek, Inc.
FDA 510(k) clearance K853291 for GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300, Substantially Equivalent on 1985-10-10. Applicant: Bio-Detek, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Detek, Inc.
- Product code
- Code HAM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
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