510(k) K903989
- Device
- SIL-MED T-TUBE DRAIN
- Applicant
- SIL-MED CORP.
- 510(k) number
- K903989
- Product code
- HFL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-01-31
- Date received
- 1990-08-29
- Regulation
- 884.3200
- Classification name
- Drain, Cervical
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM S MCCALLUM
- Address
- 700 Warner Blvd. Taunton MA US 02780 02780
FDA Registration Numbers#
- 3031162425
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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