510(k) K812542
K812542 is an FDA 510(k) premarket notification submitted by Polaroid Corp. for the device "POLAROID INSTANT ENDOCAMERA". The FDA issued a decision of Substantially Equivalent on October 19, 1981. The device falls under product code FEM (Accessories, Photographic, For Endoscope (Exclude Light Sources)), a Class I device regulated under 21 CFR 876.1500. Polaroid Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 1981
- Date Received
- September 4, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Photographic, For Endoscope (Exclude Light Sources)
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type