510(k) K964181
- Device
- SPONGETRAC
- Applicant
- SURGITRAC CORP.
- 510(k) number
- K964181
- Product code
- MRL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-02-26
- Date received
- 1996-10-18
- Regulation
- 880.2740
- Classification name
- Scale, Sponge, Surgical, Electrically-powered
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JONATHAN S KAHAN
- Address
- 555 Thirteenth St. NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3013846070
- 1000557421
- 3013484347
- 3008221237
- 3015967359
- 1929045
- 3000122543
- 3020614056
- 3007047906
- 3006897996
Source Documents#
Legacy Summary#
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FDA Review#
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