The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Specialty Sponges.
Device ID | K781420 |
510k Number | K781420 |
Device Name: | SPECIALTY SPONGES |
Classification | Gauze/sponge, Internal |
Applicant | IPCO CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-15 |
Decision Date | 1978-10-03 |