The following data is part of a premarket notification filed by Harvard Laboratories with the FDA for Suction Collection Bottle, Disposable.
Device ID | K810574 |
510k Number | K810574 |
Device Name: | SUCTION COLLECTION BOTTLE, DISPOSABLE |
Classification | Bottle, Collection, Vacuum |
Applicant | HARVARD LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDQ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-03 |
Decision Date | 1981-04-21 |