510(k) K802915
- Device
- MONTG. TRACHEAL TREPHINE FENE STRATOR
- Applicant
- BOSTON MEDICAL PRODUCTS, INC.
- 510(k) number
- K802915
- Product code
- KBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-12-19
- Date received
- 1980-11-19
- Regulation
- 874.4420
- Classification name
- Trephine, Sinus
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3017352116
- 8030607
- 9613926
- 8043368
- 1836161
- 8040278
- 9615857
- 2085199
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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