The following data is part of a premarket notification filed by Medical Perspectives Corp. with the FDA for Kittner Dissector.
Device ID | K953059 |
510k Number | K953059 |
Device Name: | KITTNER DISSECTOR |
Classification | Gauze/sponge, Internal, X-ray Detectable |
Applicant | MEDICAL PERSPECTIVES CORP. 50 AIKEN ST. UNIT 213 Norwalk, CT 06851 |
Contact | David Pieratos |
Correspondent | David Pieratos MEDICAL PERSPECTIVES CORP. 50 AIKEN ST. UNIT 213 Norwalk, CT 06851 |
Product Code | GDY |
CFR Regulation Number | 878.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-30 |
Decision Date | 1995-09-14 |