510(k) K003128
- Device
- MODIFICATION TO RELIEF BRIEF
- Applicant
- THE JM KOHN CO.
- 510(k) number
- K003128
- Product code
- NJB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-08-12
- Date received
- 2000-10-06
- Regulation
- 890.3490
- Classification name
- Orthosis, Truncal, For Dysmenorrhea
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES L MORIN
- Address
- 201 Spear St. Suite 1600 San Francisco CA US 94105 94105
FDA Registration Numbers#
- 3004555067
- 3016450032
- 3010182295
- 2950684
- 3005906953
- 3031606416
- 3017417635
- 3005237621
- 3005885000
- 3034694939
- 3005951403
- 3008808082
- 3042227943
- 3014301546
Source Documents#
Legacy Summary#
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FDA Review#
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