GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)
FDA 510(k) clearance K961444 · decided 1996-08-01
Clearance details
- K-number
- K961444
- Device name
- GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)
- Applicant
- Global Medical Products, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-15
- Decision date
- 1996-08-01
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Woodbury, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.