510(k) K844110
- Device
- Xtraceteze Surgical Skin Staple Remover 2001
- Applicant
- PELCO, INC.
- 510(k) number
- K844110
- Product code
- PYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-11-19
- Date received
- 1984-10-23
- Regulation
- 878.4760
- Classification name
- Staple Removal Kit
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- WALLACE J ROGOZINSK
- Address
- 1040 Harbor Dr. Annapolis MD US 21403 21403
FDA Registration Numbers
- 3004111573
- 1423537
- 3007329020
- 3009888344
- 1061124
- 1928237
- 1643817
- 9616088
- 3009303243
Source Documents
510(k) summary PDF not indicated by FDA