FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROLASTIC SHEETING
K Number: K954382
·
Decision Nov 29, 1995
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
44
Applicant Total
2
Review Days
71
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PROLASTIC SHEETING
- K Number
- K954382
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pillar Surgical
- Date Received
- September 19, 1995
- Decision Date
- November 29, 1995
- Product Code
- MIB
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| MIB | Elastomer, Silicone Block | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MIB), ordered by most recent decision date.
MISTI Silicone Implant
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Pre-Formed Silicone Block
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ShiNeo Silicone Implant
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AugMENTA Penile Implant
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Pre-Formed Penile Silicone Block
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BioSiCar Silicone Implant
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Pillar Surgical
| K Number | Device Name | ||
|---|---|---|---|
| K991970 | SCAREASE SHEETS & SCAREASE GEL | Oct 25, 1999 | Substantially Equivalent |