MMODIFICATION TO LAMINARIA— 510(k) K011512
Substantially EquivalentA & A Medical, Inc.
FDA 510(k) clearance K011512 for MMODIFICATION TO LAMINARIA, Substantially Equivalent on 2001-07-09. Applicant: A & A Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- A & A Medical, Inc.
- Product code
- Code HDY
- Device class
- Class 2
- Regulation
- 21 CFR 884.4260
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Recent devices under product code HDY
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- K010510 — BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1
- K010789 — CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
Data sourced from openFDA. This site is unofficial and independent of the FDA.