The following data is part of a premarket notification filed by William F. Whittingham with the FDA for Whittingham Ultraclean Phaco Handpiece.
Device ID | K972063 |
510k Number | K972063 |
Device Name: | WHITTINGHAM ULTRACLEAN PHACO HANDPIECE |
Classification | Unit, Phacofragmentation |
Applicant | WILLIAM F. WHITTINGHAM 22 FLORES Foothill Ranch, CA 92610 |
Contact | William F Whittingham |
Correspondent | William F Whittingham WILLIAM F. WHITTINGHAM 22 FLORES Foothill Ranch, CA 92610 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-03 |
Decision Date | 1997-11-25 |
Summary: | summary |