FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BA-CPAS
K Number: K945154
·
Decision Jan 13, 1995
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
41
Applicant Total
64
Review Days
84
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Basic Information
- Device Name
- BA-CPAS
- K Number
- K945154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nobelpharma USA, Inc.
- Date Received
- October 21, 1994
- Decision Date
- January 13, 1995
- Product Code
- FZE
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FZE | Prosthesis, Nose, Internal | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Nobelpharma USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE | Jun 28, 1999 | Substantially Equivalent |
| K962403 | NOBLEPHARMA WIDE ACCESSORIES | Sep 6, 1996 | Substantially Equivalent |
| K955713 | NOBELPHARMA BONE ANCHORED HEARING AID | Aug 9, 1996 | Substantially Equivalent |
| K962130 | BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE | Jul 22, 1996 | Substantially Equivalent |
| K961736 | 17 ANGULATED ABUTMENT | Jul 18, 1996 | Substantially Equivalent |
| K961737 | CERA ONE ABUTMENT SYSTEM | Jul 10, 1996 | Substantially Equivalent |
| K961728 | MIRUSCONE ABUTMENT SYSTEM | Jul 10, 1996 | Substantially Equivalent |
| K960639 | ABUTMENT SELECTION KIT | May 14, 1996 | Substantially Equivalent |
| K955697 | ABUTMENT RETRIEVAL KIT | Jan 30, 1996 | Substantially Equivalent |
| K955372 | BALL ATTACHMENT SYSTEM | Jan 23, 1996 | Substantially Equivalent |